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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 4-254
Standard
ANSI ADA Standard No. 99 - 2001 (Reaffirmed 2013)
Athletic Mouth Protectors and Materials
Scope/Abstract
This specification is for thermoplastic or thermosetting polymeric materials, with or without a polymeric shell, that are capable of being formed into an athletic mouth protector, either on a model of the teeth or in the mouth directly on the teeth. It lists the types and classes of mouth protectors and lists requirements for physical properties along with tests specified for determining compliance with those requirements It also specifies requirements for manufacturer's instructions and for packaging, labeling, and marking.
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
Unclassified Mouthguard, Migraine/Tension Headache   OCO
Unclassified Mouthguard, Over-The-Counter   OBR
Unclassified Mouthguard, Prescription   MQC
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Anita Belani
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-3944
  Anita.Belani@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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