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YY 1042-2023: Dentistry -- Polymer-based restorative materials
YY 1042-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.060.10
CCS C 33
Replacing YY 1042-2011
Dentistry - Polymer-based Restorative Materials
牙科学 聚合物基修复材料
(ISO 4049.2019, MOD)
ISSUED ON. NOVEMBER 22, 2023
IMPLEMENTED ON. DECEMBER 1, 2026
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 7
4 Classification... 7
4.1 Type... 7
4.2 Class... 8
5 Requirements... 8
5.1 Physical and Chemical Properties... 8
5.2 Shade of Restorative Materials... 10
5.3 Color Stability after Irradiation and Water Absorption... 10
5.4 Radio-opacity... 10
6 Sampling... 11
7 Test Methods... 12
7.1 General Reagent --- Water... 12
7.2 Test Environment... 12
7.3 Inspection... 12
7.4 Specimen Preparation... 12
7.5 Measurement of Film Thickness of Luting Materials... 13
7.6 Working Time of Class I and Class III Restorative Materials (except luting materials)
... 16
7.7 Working Time of Class I and Class III Luting Materials... 19
7.8 Curing Time of Class I and Class III Materials... 19
7.9 Ambient Light Sensitivity of Class II Materials... 21
7.10 Curing depth of Class II Materials (except luting materials)... 22
7.11 Flexural Strength... 24
7.12 Water Absorption Value and Dissolution Value... 28
7.13 Shade and Color Stability after Irradiation and Water Absorption... 32
7.14 Radio-opacity... 34
8 Packaging, Marking, Instructions and Information Provided by the Manufacturer. 34
8.1 Packaging... 34
8.2 Marking and Instructions for Use... 34
8.3 Declaration of Components... 38
Bibliography... 39
Dentistry - Polymer-based Restorative Materials
1 Scope
This document specifies the requirements for dental polymer-based restorative materials. This
type of material, which is provided in a form suitable for mechanical mixing, manual blending,
or intra-oral and extra-oral activation by external energy, is mainly used for direct or indirect
restoration and luting of teeth.
The polymer-based luting materials covered by this document are intended for use in the
cementation or fixation of restorations and restorative devices, such as. inlays, onlays, veneers,
crowns and bridges. This document does not cover polymer-based luting materials containing
adhesive components (see ISO/TS 16506).
This document does not cover dental polymer-based materials used to prevent dental caries (see
YY 0622), core materials or veneer materials used on metal bases (see YY 0710).
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
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 0631 Dental Materials - Determination of Color 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.
Type II. other polymer-based restorative materials and luting materials, except Type I.
4.2 Class
Dental polymer-based restorative materials are divided into the following three classes.
---Class I. materials that are cured by mixing initiators and accelerators (self-curing
materials).
---Class II. materials that are cured by activation by external energy sources, such as. blue
light or heating (see Item 9 and Item 20 in Table 4 for “external energy activated”
materials). It can be divided into the following two groups.
1) Group 1.materials that require energy activation in the oral cavity.
2) Group 2.materials that require energy activation outside the oral cavity. After
curing is completed, the materials are luted into place.
The manufacturer may claim that some materials belong to both Group 1 and Group 2.
At this time, this type of material shall simultaneously satisfy the requirements of both
groups.
NOTE. Class II luting materials only belong to Group 1.
---Class III. materials that are cured by external energy and have a self-curing mechanism
(dual curing materials).
5 Requirements
5.1 Physical and Chemical Properties
5.1.1 General requirements
If the manufacturer provides multiple shades of restorative materials, each shade, including the
opaque shade, shall be able to satisfy the various requirements of the materials for ambient light
sensitivity (5.1.7) and curing depth (5.1.8), shade (5.2) and color stability (5.3) in the
corresponding type and class. If the material provided can be “pigmented” or “mixed” in
accordance with the user’s requirements, then, the material shall comply with the requirements
when used alone and after being tinted or blended with the colorant in the maximum
recommended proportion (see Item 19 in Table 4). The curing depth (5.1.8) of the luting
materials does not need to be tested.
Unless the manufacturer claims that the material has color stability, luting materials do not need
to be tested for color stability (5.3).
For the other requirements in 5.1, and 5.4, only a representative shade of the restorative
materials shall be tested. The representative shade shall be that of a material classified as
“universal” by the manufacturer, or, if in the absence of such classification, then, the shade “A3”
of Vita1) color classification shall be taken as the representative shade. However, if the
manufacturer claims that other colors have higher radio-opacity (see 5.4 and Item 28 in Table
4), then, this claim shall be tested.
Performance requirements are summarized in Table 1, Table 2 and Table 3.
5.1.2 Film thickness of luting materials
Carry out the test in accordance with 7.5.The film thickness of the luting materials shall not be
10 m greater than the manufacturer’s claimed value, and in no case shall the film thickness be
greater than 50 m (primary requirement).
5.1.3 Working time of Class I and Class III restorative materials (except luting materials)
Carry out the test in accordance with 7.6.The working time of working time of Class I and
Class III restorative materials (except luting materials) shall be  90 s.
5.1.4 Working time of Class I and Class III luting materials
Carry out the test in accordance with 7.7.The materials shall be able to form a thin layer. During
the formation of the thin layer, there shall be no perceptible change in its uniformity.
5.1.5 Curing time of Class I materials
When carry out the test in accordance with 7.8, the curing time of Class I restorative materials
(except luting materials) shall be  5 min. When carrying out the test in accordance with 7.8,
the curing time of Class I luting materials shall be  10 min.
5.1.6 Curing time of Class III materials
When carrying out the test in accordance with 7.8, the curing time of Class III materials shall
be  10 min.
5.1.7 Ambient light sensitivity of Class II materials
When carrying out the test in accordance with 7.9, the materials shall maintain physical
uniformity.
5.1.8 Curing depth of Class II materials (except luting materials)
First requirement. when carrying out the test in accordance with 7.10, among Class II restorative
materials (except luting materials), the curing depth of materials indicated by the manufacturer
as shading shall be  1 mm, and the curing depth of other restorative materials shall be  1.5
mm.
1) Vita is a trade name of Vita Zahnfabrik, H Rauter GmbH and CoK G, Postfach 1338, D-79704 Bad
Saeckingen, Germany. The information is provided only for the convenience of users of this
document and does not constitute a clause of this document.
batch number, including the sample required for repeated tests if necessary. The sufficient
amount is 50 g.
7 Test Methods
7.1 General Reagent --- Water
The test water shall comply with Grade-2 water specified in GB/T 6682-2008.
7.2 Test Environment
Unless otherwise specified by the manufacturer, all specimen preparation and tests shall be
conducted in environment of (23  2) C. At any time, the relative humidity shall be controlled
at greater than 30% and less than 70%. If the material is refrigerated, it shall reach (23  2) C
before testing.
The determination of the working time (see 7.6) and curing time (see 7.8) of Class III materials
shall be carried out under conditions without radiation activation.
These materials can be activated by both natural and artificial light sources in the environment.
In order to control the material from being activated, the test should be conducted in a dark
chamber, and any artificial light should be filtered through a yellow filter.
7.3 Inspection
Conduct visual inspection to verify the compliance with the stipulations of Chapter 8.
7.4 Specimen Preparation
The specimens of Class II and Class III materials shall be prepared in accordance with the
external energy source specified or recommended for the material under test in the
manufacturer’s instructions for use (see Item 20 in Table 4). In addition, ensure that the external
energy source is in a satisfactory working condition (see YY 0055 for guidance).
In accordance with the manufacturer’s instructions for use and the test environment specified
in 7.2, blend the materials or prepare specimens through other methods.
For tests that require the specimen to be completely cured during the tests (7.11 ~ 7.14), it is of
great importance to ensure that the specimen taken out from the mold is uniform. When carrying
out visual inspection without a magnifying glass, there shall be no cracks, cavities,
discontinuities or bubbles in the specimen.
Some polymer-based materials, especially certain luting materials, have a chemical affinity for
base metals, making it difficult to remove the specimen from the metal mold. Therefore,
attention shall be paid to the information provided by the manufacturer (see Item 26 in Table 4)
regarding this property. If the manufacturer claims that the material has this property, then, the
molds for preparing the specimens shall be made of non-metallic materials, for example, high-
1---polyethylene tube;
2---polyamide block;
3---stainless steel tube;
4---thermocouple cone measuring probe.
Figure 3 -- Measuring Instrument for Working Time and Curing Time (see 7.6 and 7.8)
The instrument is composed as follows. a high-density polyethylene (or similar material) tube
(1) is installed on a polyamide or similar material block (2). A stainless steel tube (3) is inserted
into the hole of the polyamide block. A stable thermocouple (4) is installed in the stainless steel
tube.
Tube (1) has a length of 8 mm, an inner diameter of 4 mm and a wall thickness of 1 mm. The
diameter of the connecting part between the polyamide block (2) and the tube (1) is 4 mm, and
the height is 2 mm. The combination of the two forms a specimen tank with a height of 2 mm
and a diameter of 4 mm. In order to facilitate the removal of the specimen after the test, the top
of the thermocouple (4) is made into a cone shape and embedded 1 mm into the bottom of the
specimen tank. The tolerance of the above dimensions is  0.1 mm.
The thermocouple is wire is made of a material (for example, copper / constantan) with a
diameter of (0.20  0.05) mm and can indicate the temperature change during the curing process
of the specimen, and the temperature measurement accuracy is 0.1 C. Connect the
thermocouple to an instrument that records temperature (for example, a voltmeter or recorder),
and this instrument can record temperature to this accuracy.
7.6.1.2 Timer, with an accuracy of 1 s.
7.6.2 Steps
In accordance with the manufacturer’s instructions (see Table 4), prepare the test material and
start timing from blending. Maintain the specimen tank in an environment of (23  1) C. 30 s
after the start of blending, put the blended material into the specimen tank and record the
temperature T0 of the material. Maintain the instrument (7.6.1.1) at (23  1) C and continuously
record the temperature of the material, until the temperature exceeds the maximum value.
Figure 4 shows a typical recording curve. Once the material is placed in the specimen tank, the
temperature immediately rises slightly to T1, then, drops, until it stabilizes at T0, then, the
temperature starts to rise again. The point, at which, the temperature starts to rise, indicates the
start of the curing reaction, that is, the end of the working time. From (T0  0.1) C, draw a
horizontal baseline, and the time corresponding to the intersection of the horizontal baseline
and the rising section of the curve is the working time tw. The test result is closely related to
temperature, and small temperature changes within the allowed temperature range may cause
the test result to differ by a few seconds. The time from the start of blending to the start of
temperature rise is recorded as working time tw.
more results < 90 s, then, the material does not comply with the requirements of 5.1.3.
7.7 Working Time of Class I and Class III Luting Materials
7.7.1 Instruments
7.7.1.1 2 glass slides.
7.7.1.2 Timer, with an accuracy ...