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

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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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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 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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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 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 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 International Standard describes 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 shade guides (colour rings) in this standard.
The coordinates of tooth colours in the colour space (colour coordinates) the specification of which is left
to the manufacturers’ discretion as well as the colour deviations of ceramic and other masses or materials
used in the manufacture of dental prosthesis do not fall into the scope of this standard.
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 International Standard.
They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not
serve colour determination 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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This document specifies requirements and test methods for assessing the applicability of dental
magnetic attachments that provide retention, support and stabilization of removable prostheses
(crowns and bridges, partial dentures and overdentures), superstructures of dental implants and
orthodontic or maxillofacial prostheses including obturators.

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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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This International Standard gives the requirement for the permissible reduction in strength resulting
from crevice corrosion of dental amalgam products that are within the scope of ISO 24234: Dentistry –
Dental amalgam and ISO 20749: Dentistry – Pre-capsulated dental amalgam. It provides details of the
test procedure for determining this.

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This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

  • Standard
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This document specifies the requirements for the permissible reduction in strength resulting from crevice corrosion of dental amalgam products that are within the scope of ISO 24234 or ISO 20749. It provides details of the test procedure for determining this.

  • Standard
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  • Standard
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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 gives the details of test procedures for evaluating the corrosion resistance of dental amalgam formed from products that are within the scopes of ISO 24234 and ISO 20749. This document is not applicable to other metallic materials in which an alloy powder reacts with a liquid alloy to produce a solid metallic material intended for dental restoration.

  • Technical specification
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This standard specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

  • Standard
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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

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This document specifies requirements for dental polymer-based restorative materials supplied in a form
suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation,
and intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation
or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This
document does not cover those polymer-based luting materials that have an adhesive component within
the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core
materials or those used for veneering metal sub-frames (see ISO 10477).

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This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information.
This document is applicable to brackets and tubes for use in fixed orthodontic appliances.
This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

  • Standard
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This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

  • Standard
    38 pages
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This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting. The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506). The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

  • Standard
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  • Standard
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This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

  • Standard
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This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

  • Standard
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This document specifies requirements and test methods for laser welding and the filler materials
thereto used in the dental laboratory for welding of metallic restorations and appliances.
For filler materials used in laser welding, this document also specifies the information given in the
instructions for use, marking and labelling.

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ISO 20749:2017 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.
ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.
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.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405.
The scope of 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 within the scope of ISO 24234.

  • Standard
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ISO 20749:2017 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.
ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.
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.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405.
The scope of 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 within the scope of ISO 24234.

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MINOR REVISION

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This document specifies requirements for the physical properties, test methods, packaging, marking
and manufacturer's instructions for soft denture lining materials suitable for short-term use, including
functional impression taking using existing removable prosthesis.

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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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MINOR REVISION

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ISO 28319:2018 specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances.
For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.

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ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.

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This International Standard specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment, in combination with orthodontic appliances.
It specifies dimensions, shapes, materials and the marking.
This International Standard does not cover palatal implants used in orthodontics which are intended to osseointegrate.

  • Standard
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This document specifies the requirements for reusable mixing-capsules intended to contain dental
amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the
test methods used to determine conformity to these requirements.
NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not
dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

  • Standard
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ISO 28319:2018 specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances. For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.

  • Standard
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ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.

  • Standard
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ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.
NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

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ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment.
ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information.
NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.

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ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements. NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

  • Standard
    9 pages
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ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information. NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.

  • Standard
    6 pages
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This document specifies requirements and test methods for water-based dental cements in which
setting is achieved by a combination of an acid-base reaction and polymerization. The materials are
intended for luting, base or lining, restoration and tooth core build up purposes.
EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable
aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of
this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition
will be able to undergo setting by polymerization.
NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International
Standards ISO 4049 and ISO 9917-1 so that they can consider which is the most appropriate for evaluating any
individual product.

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This document specifies the classification, requirements, and test methods for artificial teeth such as
ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

  • Standard
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ISO 9917-2:2017 specifies requirements and test methods for water-based dental cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes.
EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization.
NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917‑1 so that they can consider which is the most appropriate for evaluating any individual product.

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ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

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