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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 050 Date of Entry 09/17/2018 
FR Recognition Number 4-243
Standard
ANSI ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013 Corrosion Test Methods
Scope/Abstract
This standard provides test methods and protocols to determine the corrosion behavior of all metallic materials used in restorative, prosthetic and orthodontic dentistry in the oral cavity, including cast, machined and prefabricated devices.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004.

Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff, 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
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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