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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 043 Date of Entry 06/27/2016 
FR Recognition Number 4-227
Standard
ISO  22674 Second edition 2016-01-15
Dentistry - Metallic materials for fixed and removable restorations and appliances
Identical Adoption
ANSI ADA Standard No. 134-2018
Metallic Materials for Fixed and Removable Restorations and Appliances
Scope/Abstract
This International Standard classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party.

This International Standard does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).
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FDA recognition of ISO 22674 Second edition 2016-01 [Rec# 4-227] will be superseded by recognition of ISO 22674 Third edition 2022-08 [Rec# 4-300].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 6, 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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