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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
Standard
ISO 9333 Second edition 2006-07
Dentistry - Brazing materials
U.S. Identical Adoption
ANSI ADA Standard No. 88-2019
Dental Brazing Alloys
Scope/Abstract
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FDA recognition of ANSI/ADA Standard No. 88 - 2000 (R2012) [Rec# 4-92] will be superseded by recognition of ANSI/ADA Standard No. 88 - 2019 [Rec# 4-264]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-92] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 4-92] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§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.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Michelle Chavis
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  --
  Michelle.Chavis@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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