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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 4-233
Standard
ISO  20795-2 Second edition 2013-03-01
Dentistry - Base polymers - Part 2: Orthodontic base polymers
Scope/Abstract
This part of ISO 20795 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.
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
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.5470 Aligner, Sequential Class 2 NXC
§872.5525 Maintainer, Space Preformed, Orthodontic Class 1 DYT
§872.5525 Positioner, Tooth, Preformed Class 1 KMY
§872.5570 Device, Jaw Repositioning Class 2 LQZ
§872.5570 Device, Anti-Snoring Class 2 LRK
§872.5570 Tongue Suspension System Class 2 ORY
N/A Mouthguard, Prescription MQC
N/A Mouthguard, Over-The-Counter OBR
N/A Mouthguard, Migraine/Tension Headache OCO
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, issued November 12, 2002.

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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