ANSI ADA Standard No. 139-2012

Standard Organization:

ANSI ADA Standard No. 139-2012
Dental Base Polymers

Recognition Date2017-08-21
Recognition List047
Recognition Number4-234
Extent Complete standard
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STG Dental/ENT
FDA Tech  Michael Adjodha   FDA/OMPT/CDRH/ODE/DAGID/DEDB   301-796-6276   michael.adjodha@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, issued November 12, 2002.

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