Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

058

Date of Entry 05/30/2022

FR Recognition Number

4-293

Standard

ANSI ADA Standard No. 119-2021
Manual Toothbrushes

Scope/Abstract

This standard describes requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. Also specified is a test method for determining the resistance of the tufted portion of manual toothbrushes to deflection. This standard is a modified adoption of ISO 20126:2012, Dentistry - Manual toothbrushes - General requirements and test methods and ISO 22254:2005, Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection.

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.

Transition Period

FDA recognition of ANSI ADA Standard No. 119-2021 [Rec# 4-293] will be superseded by recognition of ANSI ADA Standard No. 119-2023 [Rec# 4-339]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-293] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 4-293] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§872.6855	Toothbrush, Manual	Class 1	EFW

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

Standards Development Organizations