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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 4-238
Standard
ISO  20127 First edition 2005-03-15
Dentistry - Powered toothbrushes - General requirements and test methods
Identical Adoption
ANSI ADA Standard No.120-2009 (R2014)
Powered Toothbrushes
Scope/Abstract
This International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances.

This International Standard gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information.

This International Standard does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405.
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FDA recognition of ISO 20127 First edition 2005-03 [Rec# 4-238] will be superseded by recognition of ISO 20127 Second edition 2020-08 [Rec# 4-316].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.
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