Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

056

Date of Entry 06/07/2021

FR Recognition Number

4-278

Standard

ISO 4823 Fifth edition 2021-02
Dentistry - Elastomeric impression and bite registration materials

Identical Adoption

ANSI ADA Standard No. 19-2022
Elastomeric Impression and Bite Registration

Scope/Abstract

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.

NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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
§872.3660	Material, Impression	Class 2	ELW

Relevant FDA Guidance and/or Supportive Publications*

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

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