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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 055 Date of Entry 12/21/2020 
FR Recognition Number 4-264
ISO  9333 Second edition 2006-07
Dentistry - Brazing materials
Identical Adoption
ANSI ADA Standard No. 88-2019
Dental Brazing Alloys
ADA 88-2019 specifies requirements and test methods for brazing filler alloys suitable for use in brazing cast dental restorations.
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FDA recognition of ISO 9333 Second edition 2006-07 [Rec# 4-264] will be superseded by recognition of ISO 9333 Third edition 2022-08 [Rec# 4-303]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-264] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-264] 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
 Ran Huo
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.