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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 038 Date of Entry 01/27/2015 
FR Recognition Number 4-218
Standard
ISO  27020 First edition 2010-12-15
Dentistry - Brackets and tubes for use in orthodontics
U.S. Identical Adoption
ANSI ADA Standard No.100-2012
Orthodontic Brackets and Tubes
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.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.5410 Bracket, Metal, Orthodontic Class 1 EJF
§872.5410 Bracket, Metal, Orthodontic, Reprocessed Class 1 NQS
§872.5410 Tube, Orthodontic Class 1 DZD
§872.5470 Bracket, Ceramic, Orthodontic Class 2 NJM
§872.5470 Bracket, Plastic, Orthodontic Class 2 DYW
§872.5470 Bracket, Plastic, Orthodontic, Reprocessed Class 2 NLC
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 Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@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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