Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

055

Date of Entry 12/21/2020

FR Recognition Number

4-265

Standard

ISO 10271 Third edition 2020-08
Dentistry - Corrosion test methods for metallic materials

Identical Adoption

ANSI ADA Standard No. 97-2020
Corrosion Test Methods for Metallic Materials

Scope/Abstract

This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials.

This document is not applicable to dental instruments.

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
§872.3060	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. Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004.

2. Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff, 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

Michael Adjodha

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6276

michael.adjodha@fda.hhs.gov

Lauren Giles

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-9552

lauren.giles@fda.hhs.gov

Joel Anderson

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6520