Mouthguard, Over-the-counter

Boyd Research, Inc.

The following data is part of a premarket notification filed by Boyd Research, Inc. with the FDA for Clenchguard.

Pre-market Notification Details

Device IDK181005
510k NumberK181005
Device Name:ClenchGuard
ClassificationMouthguard, Over-the-counter
Applicant Boyd Research, Inc. 506 Pacific Ave Solana Beach,  CA  92075
ContactJames Boyd
CorrespondentJames Boyd
Boyd Research, Inc. 5820 Bali Way S St. Pete Beach,  FL  33706
Product CodeOBR  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-16
Decision Date2020-01-15

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