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U.S. Department of Health and Human Services

Product Classification

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Device mouthguard, over-the-counter
Definition To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Physical State It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.
Technical Method The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin
Target Area Oral Cavity
Review Panel Dental
Product CodeOBR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible