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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 4-294
Standard
ANSI ADA Standard No. 139-2020
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.

This standard is a modified adoption of ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers and ISO 20795-1:2013 Dentistry - Base polymers - Part 2: Orthodontic base polymers.
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FDA recognition of ANSI/ADA Standard No. 139-2012 [Rec# 4-234] will be superseded by recognition of ANSI/ADA Standard No. 139-2020 [Rec# 4-294]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-234] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 4-234] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Mouthguard, Migraine/Tension Headache   OCO
Unclassified Mouthguard, Over-The-Counter   OBR
Unclassified Mouthguard, Prescription   MQC
Regulation Number Device Name Device Class Product Code
§872.5470 Aligner, Sequential Class 2 NXC
Regulation Number Device Name Device Class Product Code
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
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 Tongue Suspension System Class 2 ORY
Regulation Number Device Name Device Class Product Code
§872.5525 Maintainer, Space Preformed, Orthodontic Class 1 DYT
§872.5525 Positioner, Tooth, Preformed Class 1 KMY
Relevant FDA Guidance and/or Supportive Publications*
1. Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, issued November 2002.

2. Denture Base Resins - Performance Criteria for Safety and Performance Base Pathway, issued April 2022.

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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Ran Huo
  FDA/OMPT/CDRH/OPEQ/OHT1/DHT1B
  --
  ran.huo@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
*These are provided as examples and others may be applicable.
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