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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 4-245
ISO 10271 Second edition 2011-08-01 Dentistry - Corrosion test methods for metallic materials
U.S. Identical Adoption
ANSI ADA Standard No. 97-2020
Corrosion Test Methods for Metallic Materials
This International Standard provides test methods and procedures to determine the corrosion behavior of metallic materials used in the oral cavity. It is intended that the test methods and procedures in this International Standard be referred to in the individual International Standards specifying such metallic materials.

This International Standard is not applicable to instruments and dental amalgam and appliances for orthodontics.
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
 Joel Anderson
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.