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YY/T 1937-2024Customized removable denture (English PDF)

定制式活动义齿

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 8, 2024

Implementation date

July 20, 2025

Scope

YY/T 1937-2024 is the English-translated version of 定制式活动义齿.

YY/T 1937-2024 is the Chinese standard "Customized removable denture". Its scope clause reads: This document specifies the requirements for custom-made removable dentures and describes the corresponding test methods.

This document applies to custom-made removable dentures. Its clauses include terms and definitions.

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Document preview — YY/T 1937-2024

National Standard of the People's Republic of China

ICS
11.060.10
Classification
C33

Issued by: National Medical Products Administration

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Classification and naming
  • 5 Structure
  • 6 Requirements
  • 7 Sample preparation
  • 8 Test methods
  • 9 Inspection Rules
  • 10 Marking and accompanying documents
  • 11 Packaging, transportation and storage
  • Appendix A (Normative) Requirements for custom removable denture models
  • Appendix B (Informative) Customized removable denture metal internal quality inspection method
  • References

1 Scope

This document specifies the requirements for custom-made removable dentures and describes the corresponding test methods.

This document applies to custom-made removable dentures.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

GB/T 9937-2020 Dental terminology

GB 17168-2013 Metal materials for fixed and removable restorations in dentistry

YY 0270.1-2011 Dental base polymers Part 1.Denture base polymers

YY 0300-2009 Artificial teeth for dental restoration

YY/T 0462-2018 Dental plaster products

YY/T 1702-2020 Additive manufacturing of dental fixed and removable restorations using laser selective melting of metal materials

3 Terms and definitions

The terms and definitions defined in GB/T 9937-2020 and the following apply to this document.

3.1 Customized denture

Denture manufacturers use dental materials to carry out restoration design and production according to the patient model and the requirements of the design sheet.

Medical institutions provide restorations that can restore the morphology, function and aesthetics of patients' tooth defects, edentulous spaces and missing teeth.

Note. Includes customized fixed dentures and customized removable dentures.

3.2 Restoration

Dental medical devices used to restore or replace missing tooth structure, teeth or oral tissue.

3.3

It is used to repair the patient's tooth defects or missing teeth, using the natural teeth and the mucosa and bone tissue covered by the base as support, using the retainer and base

The restoration is well-retained and can be removed and put on by the patient.

Note. Includes removable partial dentures and complete dentures.

3.4

A removable denture that replaces only some of the teeth in one arch, but not all of them.

3.5 Complete denture

Removable dentures for maxillary or mandibular edentulous patients.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

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