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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 4-234
Standard
ANSI ADA Standard No. 139-2012
Dental Base Polymers
Scope/Abstract
The standard is presented in two parts: 1). Denture-base polymers; and 2). Orthodontic-base polymers. Part 1 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the 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. Furthermore it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. Part 2 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
§872.5570 Device, Anti-Snoring Class 2 LRK
§872.5570 Device, Jaw Repositioning Class 2 LQZ
§872.5570 Prelude Tongue Suspension System Class 2 ORY
§872.5525 Maintainer, Space Preformed, Orthodontic Class 1 DYT
§872.5525 Positioner, Tooth, Preformed Class 1 KMY
§872.5470 Aligner, Sequential Class 2 NXC
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
Unclassified Mouthguard, Migraine/Tension Headache   OCO
Unclassified Mouthguard, Over-The-Counter   OBR
Unclassified Mouthguard, Prescription   MQC
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.
FDA Technical Contact
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  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
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