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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 4-300
Standard
ISO  22674 Third edition 2022-08
Dentistry - Metallic materials for fixed and removable restorations and appliances
Identical Adoption
ANSI ADA Standard No. 134-2023
Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
Scope/Abstract
This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document specifies requirements for packaging and marking of the products and for the instructions for use of these materials, including products delivered for sale to a third party.

This document does not apply to alloys for dental amalgam (see ISO 24234), dental brazing materials (see ISO 9333), or metallic materials for orthodontic appliances (e.g. wires, brackets, bands and screws).

This document is not applicable to magnetic attachment, which are specified in ISO 13017.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 22674 Second edition 2016-01-15 [Rec# 4-227] will be superseded by recognition of ISO 22674 Third edition 2022-08 [Rec# 4-300]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-227] until July 06, 2025. After this transition period, declarations of conformity to [Rec# 4-227] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3710 Alloy, Metal, Base Class 2 EJH
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Noble Metal Alloys, issued August 2004.

2. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Base Metal Alloys, issued August 2004.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Ran Huo
  FDA/OMPT/CDRH/OPEQ/OHT1/DHT1B/
  --
  ran.huo@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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