YY 1042-2023 Dentistry - Polymer-based restorative materials
1 Scope
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 YY 0622), core materials or those used for veneering metal sub-frames (see YY 0710).
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 6682-2008 Water for analytical laboratory use - Specification and test methods (ISO 3696: 1987, MOD)
GB/T 9937 Dentistry - Vocabulary (GB/T 9937-2020, ISO 1942:2009, MOD)
YY/T -2008 Dental materials - Determination of colour stability (YY/T 0631-2008, ISO 7491:2000, IDT)
YY/T 1599 Dentistry - Test method for polymerization shrinkage of polymer-based restorative materials - Laser ranging method
YY/T 1646-2019 Dentistry - Test method for determining radio-opacity of materials (ISO 13116:2014, IDT)
ISO 8601-1:2019 Date and time - Representations for information interchange Part 1: Basic rules
Note: GB/T 7408-2005 Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601: 2000, IDT)
ISO 8601.2:2019 Date and time - Representations for information interchange Part 2: Extensions
Note: GB/T 7408-2005 Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601: 2000, IDT)
ISO 17304 Dentistry - Polymerization shrinkage: Method for determination of polymerization shrinkage of polymer-based restorative materials
3 Terms and definitions
For the purposes of this standard, the terms and definitions specified in GB/T 9937 as well as the followings apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——ISO online browsing platform: available at https://www.iso.org/obp;
——IEC Electropedia: available at http://www.electropedia.org/.
3.1
opaque
shade of an intensely pigmented polymer-based restorative material of low translucency
3.2
outer pack
form of packaging used to combine a number of single dose containers or capsules
3.3
outmost packaging
form of packaging used to combine material and additional items, including instructions for use and any proportioning or mixing devices, that are supplied with the material
3.4
container
capsule
primary packaging of the material
4 Classification
4.1 Type
For the purposes of this document, dental polymer-based restorative materials are classified into the following types.
Type I: Polymer-based restorative materials claimed by the manufacturer as suitable for restorations involving occlusal surfaces;
Type II: All other polymer-based restorative materials and luting materials, except Type I materials.
4.2 Class
The three classes of dental polymer-based restorative materials are as follows:
——Class I: Materials whose setting is affected by mixing an initiator and activator (“Self- curing” materials).
——Class II: materials whose setting is affected by the application of energy from an external source, such as blue light or heat ("external-energy-activated" materials, see Items 9 and 20 in Table 4). They are subdivided as follows:
1) Group 1: Materials whose use requires the energy to be applied intra-orally;
2) Group 2: Materials whose use requires the energy to be applied extra-orally. When fabricated, these materials will be luted into place.
Certain materials may be claimed by manufacturers to be both Group 1 and Group 2. In this event the material shall fulfill the requirements for both groups.
Note: Class II luting materials fall into Group 1 only.
——Class III: Materials that are cured by the application of external energy, and also have a self-curing mechanism present (“dual-cure” materials).
5 Requirements
5.1 Physical and chemical properties
5.1.1 General
If a restorative material is supplied by the manufacturer in various shades, each shade, including opaque shades, shall be capable of satisfying all the requirements for sensitivity to the dental operating light (5.1.7), depth of cure (5.1.8), shade (5.2) and colour stability (5.3) appropriate to the material type and class. If the material is supplied such that it can be “tinted” or “blended” to the user’s prescription, the material shall conform to the requirements both when used alone and when used with the maximum recommended proportion of tint or blender (see Table 4, item 19). Depth of cure (5.1.8) of luting materials shall not be tested.
Colour stability (5.3) of luting materials shall not be tested unless the manufacturer claims such a property.
In respect of the other requirements of 5.1 and those of 5.4, only one representative shade of restorativen materials shall be tested. This representative shade shall be either that classified by the manufacturer as “Universal” or, in the event that no shade is so classified, that shade corresponding to “A3” in the Vita[) Vita® is a trade name of Vita Zahnfabrik, H Rauter GmbH & Co K G, Postfach 1338, D-79704 Bad Saeckingen, Germany This information is given for the convenience of the users of this document and does not constitute an endorsement of this document.]) classification of shade. However, if the manufacturer claims a higher value for radio-opacity (see 5.4 and Table 4, item 28) for any other shade, this claim shall be tested.
The requirements are summarized in Tables 1, 2 and 3.
5.1.2 Film thickness of luting materials
The film thickness of luting materials when determined in accordance with 7.5 shall be no more than 10 μm above any value claimed by the manufacturer and in any event shall be no greater than 50 μm (primary requirement).
5.1.3 Working time of Class I and Class III restorative materials, excluding luting materials
The working time for Class I and Class III restorative materials, excluding luting materials, determined in accordance with 7.6, shall be no less than 90 s.
5.1.4 Working time, Class I and Class III luting materials
When tested in accordance with 7.7, the material shall be capable of forming a thin layer; during its formation there shall be no detectable change in its homogeneity.
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 Type
4.2 Class
5 Requirements
5.1 Physical and chemical properties
5.2 Shade of restorative materials
5.3 Colour stability after irradiation and water sorption
5.4 Radio-opacity
6 Sampling
7 Test methods
7.1 General reagent - Water
7.2 Test conditions
7.3 Inspection
7.4 Preparation of test specimens
7.5 Measurement of film thickness of luting materials
7.6 Working time of Class I and Class III restorative materials, excluding luting materials
7.7 Working time, Class I and Class III luting materials
7.8 Setting time of Class I and Class III materials
7.9 Sensitivity to light, Class II materials
7.10 Depth of cure, Class 2 materials excluding luting materials
7.11 Flexural strength
7.12 Water sorption and solubility
7.13 Shade and colour stability after irradiation and water sorption
7.14 Radio-opacity
8 Packaging, marking, instructions and information to be supplied by the manufacturer
8.1 Packaging
8.2 Marking and instructions for use
8.3 Declaration of components
Bibliography
