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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 4-236
Standard
ANSI ADA Standard No. 119-2015
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 test method is applicable to toothbrushes having a conventional, flat trim design and may not be applicable to toothbrushes with other designs. Specifically excluded from this standard are manual interdental brushes and powered oral hygiene devices as these instruments are covered by separate standards.
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FDA recognition of ANSI/ADA Standard No. 119-2015 [Rec# 4-236] will be superseded by recognition of ANSI/ADA Standard No. 119-2021 [Rec# 4-293]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-236] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 4-236] 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
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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