Standard No.:	YY 1042-2011
English Name:	Dentistry—Polymer-based restorative materials
Chinese Name:	牙科学 聚合物基修复材料
Chinese Classification:	C33    Stomatologic device, equipment and material
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.060.10 11.060.10    Dental materials 11.060.10
Issued by:	China Food and Drug Administration
Issued on:	2011-12-31
Implemented on:	2013-6-1
Status:	to be superseded
Superseded by:	YY 1042-2023 Dentistry--Polymer-based restorative materials
Superseded on:	2026-12-1
Superseding:	YY 1042-2003 Dentistry - Polymer-based filling, restorative and luting materials
Language:	English
File Format:	PDF
Word Count:	13000 words
Price(USD):	320.0
Delivery:	via email in 1 business day

1 Scope This standard 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 this standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material. This International Standard does not cover materials intended to prevent caries (see YY 0622-2008) or those used for veneering metal sub-frames (see YY 0710). 2 Normative References The following referenced documents are indispensable for the application 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 Water for Analytical Laboratory Use—Specification and Test Methods (GB/T 6682-2008, ISO 3696:1987, MOD) GB/T 7408 Data Elements and Interchange Formats—Information Interchange—Representation of Dates and Times (GB/T 7408-2005, ISO 8601:2000, IDT) GB/T 9937 (All parts) Dental Vocabulary [ISO 1942 (All parts)] YY/T 0631 Dental Materials—Determination of Colour Stability (YY/T 0631-2000, ISO 7491:2000, IDT) ISO 3665 Photography—Intra-oral Dental Radiographic Film—Specification 3 Terms and Definitions For the purposes of this document, the terms and definitions given in GB/T 9937 and the following apply.

Foreword i Introduction iii 1 Scope 2 Normative References 3 Terms and Definitions 4 Classification 5 Requirements 5.1 Biocompatibility 5.2 Physical and Chemical Properties 5.3 Shade, Restorative Materials 5.4 Colour Stability after Irradiation and Water Sorption 5.5 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, 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, Class I and Class III Materials 7.9 Sensitivity to Ambient Light, Class II Materials 7.10 Depth of Cure, Class II 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 8.3 Manufacturer’s Instructions and Information for the User 8.4 Chinese Markings Bibliography