ISO/TC 106/SC 1 - Filling and restorative materials

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.

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.

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.

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.

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.

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).

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.

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.

ISO/TS 16506:2017 specifies test methods and information of bond strength to dentine and physical and chemical performances of dental polymer-based luting materials containing adhesive components. The materials are supplied in a form suitable for mechanical mixing or hand-mixing, including using auto-mixing tips, for self-curing and/or external energy activation, or non-mixing for external energy activation. The polymer-based luting materials covered by this document are intended to be used for the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, posts, crowns and bridges. ISO/TS 16506:2017 does not cover the following polymer-based luting materials: a) those which do not have an adhesive component within the structure of the material (see ISO 4049); b) those intended for veneering sub-frames (see ISO 10477).

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.

ISO/TS 20746:2016 gives the practical details of the test method for the measurement of the strength of a dental amalgam by the Hertzian indentation strength test (HIT) method. It is applicable to dental amalgam formed from products that are within the scope of ISO 24234 and ISO 20749.

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

ISO 6874:2015 specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth. It covers both self-curing and external-energy-activated materials.

ISO 13116:2014 specifies test methods for determination of radio-opacity of a test material by reference to a specimen of an aluminium standard. The method is designed to discriminate radio-opacity at a clinically meaningful level and is not designed to take account of factors which may affect precise, inherent values of radio-opacity such as background noise, X-ray beam power, grey scale correction and image enhancement. It is recognized that such factors can change the value of radio-opacity but not the relative ranking compared to standard thicknesses of an internal standard such as aluminium. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus.

ISO 15841:2014 specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. ISO 15841:2014 gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labelling information.

ISO 17304:2013 specifies a test method for the measurement of the polymerization shrinkage of external energy-activated polymer-based restorative materials such as composites and core materials.

ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.

ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.

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.

ISO 9917-1:2007 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. ISO 9917-1:2007 is applicable to both hand-mixed and capsulated cements for mechanical mixing. ISO 9917-1:2007 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. ISO 9917-1:2007 is not intended to address resin-modified water-based cements.

ISO 21606:2007 is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

Specifies requirements and test methods for dental absorbent points used in endodontic procedures.

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.

ISO 24234:2015 specifies the requirements and test methods for dental amalgam alloys 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 (including those for dental mercury). It is applicable to dental amalgam alloys supplied in the form of a free-flowing powder in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).

ISO/TS 11405:2015 gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A. ISO/TS 11405:2015 does not include requirements for adhesive materials and their performance.

ISO/TS 17988:2014 gives details of test procedures for evaluating the corrosion resistance of dental amalgam produced from a dental amalgam alloy product. It is applicable to dental amalgam formed from products that are within the scope of ISO 24234.

ISO 27020:2010 is applicable to brackets and tubes for use in fixed orthodontic appliances. ISO 27020:2010 gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information.

ISO 9917‑2:2010 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.

ISO 4049:2009 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 cavities in the teeth and for luting. The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material.

ISO 15841:2006 specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. ISO 15841:2006 gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, packaging, and labelling information.

ISO 6877:2006 specifies the dimensions and compositional requirements for prefabricated metal or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. It also specifies numerical systems and a colour coding system for designating the sizes. Dental root-canal obturating points are marketed sterilized or unsterilized. ISO 6877:2006 covers the physical attributes expected of such products as supplied. Requirements for sterility are not included, and any claim that the product is sterile is the responsibility of the manufacturer.

ISO 6874:2005 specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth. ISO 6874:2005 covers both self-cured and external-energy-activated materials.

ISO 24234:2004 specifies the requirements and test methods for alloys and for mercury suitable for the preparation of dental amalgam, together with the requirements and test methods for that amalgam and the requirements for packaging and marking. It is applicable to alloys supplied in the form of either a powder in bulk, or a powder compressed to form a tablet, or a powder in predosed capsules. It is applicable to dental mercury supplied either in bulk quantities, or in predosed sachets, or in predosed capsules. ISO 24234:2004 does not exclude the supply of alloy or mercury separately. ISO 24234:2004 is not applicable to alloys intended for use with liquid metals that are not mercury, nor is it applicable to liquid metal alloys.

ISO 3107:2004 specifies the requirements and performance test methods for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for permanent cementation, for cavity liners and bases and as temporary restorations. ISO 3107:2004 is also applicable to non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.

ISO/TS 17576:2004 provides two test methods and concomitant protocols to determine the corrosive behaviour of dental amalgams and their tendency to release mercury vapour during corrosion. The methods measure 1) the integrated current in a potentiostatic corrosion test and 2) the amount of released ions and mercury vapour in a static immersion test. ISO/TS 17576:2004 is not intended to set limits for the relevant parameters in the two tests described.

ISO 9917-1:2003 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed cements and encapsulated cements for mechanical mixing. It specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a restorative material, a base or a liner. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 9917, but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO 7405, Dentistry -- Preclinical evaluation of biocompatibility of medical deviced used in dentistry -- Test methods for dental materials, and ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing.

ISO 11405:2003 gives guidance on substrate selection, storage and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It specifies two bond strength measurements tests (tensile and shear), a test for measurement of marginal gaps around fillings and a microleakage test, as well as giving recommendations on clinical usage tests for such materials. It also presents some specific test methods for bond strength measurements.

Specifies requirements and test methods for alloys composed mainly of silver, tin and copper. The alloy may be in either powder or tablet form, or in capsules with portions of alloy and mercury predosed by the manufacturer, suitable for the preparation of dental amalgam. Replaces the second edition, of which it constitutes a technical revision.

Specifies the dimensions and compositional requirements for prefabricated metallic or polymeric-based points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. Also specifies numerical systems and a colour coding system for designating the sizes. Covers the physical attributes expected of such products as supplied.

Specifies test methods for evaluation of the adhesive bond between dental materials and tooth structure, i. e. enamel and dentine. Describes two bond strength measurement tests, tensile and shear, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials.

Changes, at both chemical type entries for zinc phosphate in table 1, the erosion limit from 0,1 to 1,0.

Specifies requirements for dental cements as follows: silicate cements, zinc phosphate cements, silicophosphate cements, zinc polycarbonate cements and glass polyalkenoate cements.