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 061 Date of Entry 12/18/2023 
FR Recognition Number 4-316
Standard
ISO  20127 Second edition 2020-08
Dentistry - Physical properties of powered toothbrushes
Identical Adoption
ANSI ADA Standard No.120-2022
Dentistry - Physical Properties of Powered Toothbrushes
Scope/Abstract
This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.

There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are:
- a battery;
- a motor;
- a mechanical or magnetic drive system;
- a moving brush head with tufted filaments.

Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities.
...
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FDA recognition of ISO 20127 First edition 2005-03 [Rec# 4-238] will be superseded by recognition of ISO 20127 Second edition 2020-08 [Rec# 4-316]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-238] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-238] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.6865 Toothbrush, Powered Class 1 JEQ
§872.6865 Toothbrush, Ionic, Battery-Powered Class 1 MMD
872.6866 Powered Radiofrequency Toothbrush Class 2 QMJ
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
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
-
-