This document specifies test methods for the evaluation of dental restorative materials that are claimed by their respective manufacturers to exert “antibacterial” effects.
This document does not cover tests on the effectiveness of sterilization or disinfection procedures nor shall it be used to demonstrate lack of microbial contamination of medical devices used in dentistry.

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Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative material. This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.

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This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements.
This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.

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This document specifies the characteristics of polymer-based composite machinable blanks with
respect to the milling process and provides the test methods that address the clinical issues specific
to those materials. In addition, this document specifies the items to be described on the packaging and
materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for
fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes.
They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of
crowns or bridges from one blank or materials for temporary use.

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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects.
NOTE       Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document.
This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.

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This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.
This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.
This document is restricted to dental amalgam products marketed in pre-capsulated form, alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are described in ISO 24234.

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This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects. NOTE Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document. This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.

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This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration. This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document is restricted to dental amalgam products marketed in pre-capsulated form, alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are described in ISO 24234.

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This document specifies the classification of and requirements for waxes used for dental casting (including products intended for CAD/CAM milling) using the lost-wax technique and dental baseplate preparation together with the test methods to be employed to determine compliance with these requirements.
Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins used in additive processes, are not covered by this document.
This document does not include specific and quantitative requirements for freedom from biological hazards.

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This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of crowns or bridges from one blank or materials for temporary use.

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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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This document gives guidance on substrate selection, storage and handling as well as essential characteristics of tensile bond strength test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. Some specific test methods for tensile bond strength measurements are given in Annex A. This document does not include requirements for components of adhesive materials and their performance.

  • Technical specification
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  • Technical specification
    17 pages
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This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and materials, as well as descriptions to be included in the instructions for use. The polymer-based composite machinable blanks covered in this document are blanks that are used for fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of crowns or bridges from one blank or materials for temporary use.

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    18 pages
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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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This document specifies the requirements for acrylic hard type materials used as chairside denture
base relining materials and the test methods to determine compliance with these requirements. This
document also specifies requirements for packaging and marking the products and for the instructions
for use to be supplied by the manufacturer.
Dentures which are relined by chairside denture base relining materials specified by this document are
limited to those of acrylic.
This document is not applicable to either denture base relining materials that are for laboratory use or
soft lining materials.
NOTE 1 Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and
substituted (meth)acrylic acid esters and their polymers.
NOTE 2 Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid
esters) and rubber-modified poly (methacrylic acid esters).

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This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer.
Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic.
This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials.
NOTE 1    Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers.
NOTE 2    Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

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This document specifies test methods for machinable ceramic blanks used for the fabrication of dental fixed restorations. This document also specifies the contents of the test report.

  • Standard
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This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic. This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials. NOTE 1 Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers. NOTE 2 Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

  • Standard
    12 pages
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  • Standard
    13 pages
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This document specifies the classification of and requirements for waxes used for dental casting (including products intended for CAD/CAM milling) using the lost-wax technique and dental baseplate preparation together with the test methods to be employed to determine compliance with these requirements. Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins used in additive processes, are not covered by this document. This document does not include specific and quantitative requirements for freedom from biological hazards.

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  • Standard
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ISO 3107:2011 specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
ISO 3107:2011 also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.

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This document specifies the requirements and test methods for dental brazing materials suitable for
use in metallic restorations.
Brazing materials with silver as the main component are excluded from this document.

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This document specifies test methods for machinable ceramic blanks used for the fabrication of dental fixed restorations. This document also specifies the contents of the test report.

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This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than eugenol for temporary cementation.

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This document specifies requirements and test methods for metallic materials that are suitable for the
fabrication of dental restorations and appliances. Included are metallic materials recommended for use
either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document
specifies requirements for packaging and marking of the products and for the instructions for use of
these materials, including products delivered for sale to a third party.
This document does not apply to alloys for dental amalgam (see ISO 24234), dental brazing materials
(see ISO 9333), or metallic materials for orthodontic appliances (e.g. wires, brackets, bands and screws).
This document is not applicable to magnetic attachment, which are specified in ISO 13017.

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This document specifies the requirements and their test methods applicable to all elastomeric
auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and
removable appliances.

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This document specifies the requirements and test methods for dental brazing materials suitable for use in metallic restorations.
Brazing materials with silver as the main component are excluded from this document.

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This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document specifies requirements for packaging and marking of the products and for the instructions for use of these materials, including products delivered for sale to a third party.
This document does not apply to alloys for dental amalgam (see ISO 24234), dental brazing materials (see ISO 9333), or metallic materials for orthodontic appliances (e.g. wires, brackets, bands and screws).
This document is not applicable to magnetic attachment, which are specified in ISO 13017.

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This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than eugenol for temporary cementation.

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    10 pages
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  • Standard
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This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

  • Standard
    16 pages
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This document specifies the requirements and test methods for dental brazing materials suitable for use in metallic restorations. Brazing materials with silver as the main component are excluded from this document.

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    10 pages
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  • Standard
    11 pages
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This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document specifies requirements for packaging and marking of the products and for the instructions for use of these materials, including products delivered for sale to a third party. This document does not apply to alloys for dental amalgam (see ISO 24234), dental brazing materials (see ISO 9333), or metallic materials for orthodontic appliances (e.g. wires, brackets, bands and screws). This document is not applicable to magnetic attachment, which are specified in ISO 13017.

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  • Standard
    44 pages
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This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

  • Standard
    8 pages
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  • Standard
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This document specifies test methods for machinable ceramic blanks used for the fabrication of dental fixed restorations. This document also specifies the contents of the test report.

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    19 pages
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This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied.
Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use.
This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

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This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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This document establishes the specifications for the dimensions of various endodontic obturating
materials including preformed metal, preformed polymeric-coated metal, polymeric points,
thermoplastic obturating material or combinations of the above, suitable for use in the obturation of
the root canal system. This document also specifies numerical systems and a colour-coding system for
designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers
the physical attributes expected of such products as supplied.
Sterility is not included in this document, and any claim that the product is sterile is the responsibility
of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for
use.
This document does not apply to instruments or apparatus used in conjunction with thermoplastic
obturating materials (obturating material that deform with heat). This document is not applicable to
materials for support of a coronal restoration.

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This document specifies the requirements and test methods for hydrocolloid impression materials. This
document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression
materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also
specifies requirements for labelling and instructions for use. This document does not address possible
biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405
and the ISO 10993 series.

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2020-11-12 - TC decision is missing to skip FV.

  • Amendment
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This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
NOTE     This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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    41 pages
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This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

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  • Standard
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  • Standard
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  • Standard
    19 pages
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This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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  • Standard
    46 pages
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  • Standard
    48 pages
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  • Standard
    48 pages
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This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam. This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount required to make a small to medium-sized restoration in a single tooth. This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.

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  • Standard
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This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

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This document specifies the requirements and their test methods for elastomeric impression and bite
registration materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment
of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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    41 pages
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This document specifies requirements for tooth-like colour representations made of ceramic materials used to determine the tooth colour in the patient's mouth or to check the colour of dental prosthesis, which are referred to as colour tabs in this document.
The colour coordinates of colour tabs are left to the manufacturers' discretion.
Resources for visualizing the colours of ceramic and other masses, e.g. mass shade guides and colour patterns for certain ceramic and other masses, do not fall into the scope of this document. They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not serve to determine colour inside the mouth.

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This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials.
This document is not applicable to dental instruments.

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    43 pages
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This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

  • Standard
    33 pages
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    33 pages
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  • Standard
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