Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019

FR Recognition Number

4-254

Standard

ANSI ADA Standard No. 99-2001 (R2013)
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
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*

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

Anita Belani

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-3944

Anita.Belani@fda.hhs.gov

Standards Development Organizations