| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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047
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Date of Entry 08/21/2017
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|
FR Recognition Number
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4-234
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| Standard | |
ANSI ADA Standard No. 139-2012
Dental Base Polymers |
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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. |
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| Extent of Recognition
|
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. |
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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| FDA recognition of ANSI/ADA Standard No. 139-2012 [Rec# 4-234] will be superseded by recognition of ANSI/ADA Standard No. 139-2020 [Rec# 4-294].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. |
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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*
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. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
