Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021

FR Recognition Number

4-285

Standard

ANSI ADA Standard No. 37-1986 (R2020)
Dental Abrasive Powders

Scope/Abstract

This standard is for powdered abrasive materials used in dentistry for removing stains and gross scratches from natural tooth structures and prostheses but not including materials used in laboratory blasting processes. These materials are divided into types depending on the intended manner of use and further sub-divided into classes based upon the predominant abrasive agent present in the product.

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
§872.6030	Agent, Polishing, Abrasive, Oral Cavity	Class 1	EJR

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

Bobak Shirmohammadi

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

301-796-3639

Bobak.Shirmohammadi@fda.hhs.gov

Standards Development Organizations