Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 064 Date of Entry 05/26/2025 
FR Recognition Number 4-339
Standard
ANSI ADA  Standard No. 119-2023
Dentistry-Manual Toothbrushes
Scope/Abstract
This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.

This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer.

This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials.

In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0.1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.
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FDA recognition of ANSI ADA Standard No. 119-2021 [Rec# 4-293] will be superseded by recognition of ANSI ADA Standard No. 119-2023 [Rec# 4-339].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
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
-
-