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Dentistry - Polymer-based crown and veneering materials
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Basic data | Standard ID | YY 0710-2025 (YY0710-2025) | | Description (Translated English) | Dentistry - Polymer-based crown and veneering materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 27,289 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2028-07-01 | | Older Standard (superseded by this standard) | YY 0710-2009 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the classification and requirements for polymer-based dental crowns and veneers, and describes the experimental methods used to determine compliance with these requirements. This document applies to polymer-based crown and veneer materials used in dental labs (dental fabrication labs or dental technology labs) for the fabrication of formal crowns or veneers. It also applies to polymer-based crown and veneer materials that manufacturers claim can bond to the substrate without the need for macroscopic mechanical retention (e.g., beads or filaments). | YY 0710-2025: Dentistry - Polymer-based crown and veneering materials---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0710-2009
Dental polymer-based crowns and veneers
(ISO 10477.2020, MOD)
Published on 2025-06-18
Implemented on 2028-07-01
National Medical Products Administration issued
Table of contents
Preface III
Introduction V
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.Classification 2
5 Requirements 2
5.1 Overview 2
5.2 Curing Depth 3
5.3 Surface Polishability 3
5.4 Flexural strength 3
5.5 Bond strength 3
5.6 Water absorption value 4
5.7 Solubility value 4
5.8 Color consistency 4
5.9 Color stability 4
6.Sampling 4
6.1 For all experiments 4
6.2 Color consistency test 4
6.3 Color stability test 4
7 Measurement and Test Methods 5
7.1 General Requirements 5
7.2 Visual Inspection 5
7.3 Curing Depth 5
7.4 Surface Polishability 6
7.5 Flexural strength 7
7.6 Bond strength 10
7.7 Water absorption and solubility value 14
7.8 Color consistency and color stability 16
8.Packaging and Labeling 18
8.1 Packaging 18
8.2 Tag 18
9.Instruction Manual 19
References 20
Foreword
This document is in accordance with GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting is scheduled.
This document replaces YY 0710-2009 "Polymer-Based Crown and Bridge Materials in Dentistry". Compared with YY 0710-2009, the only changes are structural adjustments.
Aside from editorial changes, the main technical changes are as follows.
---The statement "This document does not apply to polymer-based materials used in direct dental restorations, such as crowns, veneers, or repairs" has been removed (see.2009).
Chapter 1 of the edition);
---The requirements for ambient light sensitivity and the corresponding tests have been removed (see 5.2 and 7.3 in the.2009 edition);
---The category 2, Class 1 materials includes "pre-cured polymer-based crowns and veneers" (see Chapter 4);
---Biocompatibility has been removed (see 5.1 in the.2019 version);
---A footnote b has been added to Table 1."If the material is a pre-cured polymer-based crown or veneer, no testing is required" (see Table 1);
---The sample preparation process has been expanded to include additional requirements for the preparation of pre-cured polymer-based crowns and veneers (see 7.4, 7.5.3.1, 7.7.3).
7.8.4);
---The specific grit size range has been added after the sandpaper grade (see 7.5.2.3);
---The thickness of the water absorption value and solubility value samples, as well as the color consistency and color stability samples, has been changed from "(1.0±0.2) mm" to
"(1.0±0.1)mm" (see 7.7.3, 7.8.4, and 7.8.3 and 7.9.4 in the.2019 edition);
---The requirements for specimens in color consistency and color stability have been changed (see 7.8.4, 7.9.4 in the.2009 edition);
This document is modified to adopt ISO 10477.2020 "Dentistry - Polymer-based crowns and veneers".
Compared with ISO 10477.2020, this document has undergone the following structural adjustments.
---Move the content on biocompatibility 5.10 to the introduction.
The technical differences between this document and ISO 10477.2020, and the reasons therefor, are as follows.
---ISO 6507-1 (see 5.2) has been replaced with the normatively referenced GB/T 4340.1 to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 3696 (see 7.1.2, 7.5.2.5, 7.7.2.5) has been replaced with the normatively referenced GB/T 6682 to accommodate my country's technical requirements.
Conditions, increasing operability;
---ISO 8601 (see 8.2.2) has been replaced with the normatively referenced GB/T 7408 to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 6344-1 (see 7.5.2.3) has been replaced with the normatively referenced GB/T 9258.1 to adapt to my country's technical conditions, and the following has been added.
Operability;
---ISO 1942 has been replaced with the normatively referenced GB/T 9937 (see Chapter 3) to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 22674 has been replaced with the normatively referenced GB 17168 (see 7.6.1.1.2, 7.6.2.1.2) to adapt to my country's technical requirements.
Add components to increase operability;
---ISO 7491 (see 5.8.5.9.7.2, 7.8.1, 7.8.2.6, 7.8.6) has been replaced with the normatively referenced YY/T 0631 to suit my needs.
The country's technical conditions increase operability;
---Chapter 4 Classification, Type 2 Class 1 materials have been expanded to include "pre-cured polymer-based crowns and veneers" (see Chapter 4) to suit...
In response to market demand;
---Footnote b has been added to Table 1 to better reflect practical applications;
---The requirement of "not less than 5 MPa" has been added (see 5.5.2, 5.5.2 in Table 2, and 7.6.1.5.2) to meet the minimum requirement of 5.5.1;
---Added test method 2 for bond strength and Figure 4 (see 7.6.2) to increase operability;
---In sample preparation, additional requirements have been added for the preparation of pre-cured polymer-based crowns and veneers (see 7.4, 7.5.3.1).
(7.7.3, 7.8.4) to increase operability;
---Add a specific grit size range after the sandpaper grade (see 7.5.2.3) to increase operability;
The following editorial changes have also been made to this document.
---Corrected typos in ISO 10477.2020 regarding the thickness of samples for water absorption and solubility values, as well as color consistency and color stability.
The value of “(1.0±0.2)mm” is corrected to “(1.0±0.1)mm” (see 7.7.3 and 7.8.4).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Dental Materials and Instruments (SAC/TC99).
The release history of this document and the document it replaces is as follows.
---First released in.2009 as YY 0710-2009;
---This is the first revision.
Introduction
This document does not include specific qualitative and quantitative testing methods to demonstrate the absence of unacceptable biohazards, but recommends using these methods when assessing potential biological hazards.
When studying the hazards, refer to GB/T 16886.1 and YY/T 0268.
Dental polymer-based crowns and veneers
1 Scope
This document specifies the classification and requirements for polymer-based dental crowns and veneers, and describes the tests used to determine whether these requirements are met.
method.
This document applies to polymer-based crowns and veneers used in dental labs (dental fabrication labs or dental technology labs) for the fabrication of formal crowns or veneers.
Materials are also suitable for polymer-based materials that manufacturers claim can bond to substrate structures without the need for macroscopic mechanical fixation (such as beads or threads).
Dental crowns and veneers.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 4340.1 Metallic materials – Vickers hardness test – Part 1.Test methods (GB/T 4340.1-2009, ISO 6507-1.
2005, MOD)
GB/T 6682 Specifications and test methods for water used in analytical laboratories (GB/T 6682-2008, ISO 3696.1987, MOD)
GB/T 7408 Data Elements and Interchange Formats - Information Interchange - Representation of Date and Time (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB/T 9258.1 Abrasive grain size analysis for coated abrasives – Part 1.Grain size composition (GB/T 9258.1-2000)
ISO 6344-1.1998, IDT
GB/T 9937 Terminology in Dentistry (GB/T 9937-2020, ISO 1942.2009, MOD)
GB 17168 Metallic materials for fixed and removable dental restorations (GB 17168-2013, ISO 22674.2006, IDT)
YY/T 0631-2008 Determination of color stability of dental materials (ISO 7491.2000, IDT)
3 Terms and Definitions
The terms and definitions defined in GB/T 9937 and the following terms and definitions apply to this document.
ISO and IEC maintain a standardized terminology database at the following address.
---IEC Electropedia. http.//ww.Electropedia.org.
Composed of powders, liquids, or pastes, it may contain monomers, inorganic fillers, and/or polymer fillers, and after polymerization, it is suitable for making formal dental crowns or...
Veneer.
Note 1.(Material) polymerization is activated by mixing initiators and catalysts (“self-curing” materials) and/or by external energy (“thermosetting” materials) through heating.
And photoactivated materials irradiated by visible light (“photocurable” materials) and/or by ultraviolet (UV) irradiation.
Note 2.Polymer-based crown and veneer materials used in dental labs (dental fabrication labs or dental craft labs) for the fabrication of formal veneers or crowns may or may not be used.
Attached to the substrate structure.
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