Recognized Consensus Standards: Medical Devices

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.

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*

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