NTI ClenchGuard

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 Nti Clenchguard.

Pre-market Notification Details

Device IDK211158
510k NumberK211158
Device Name:NTI ClenchGuard
ClassificationMouthguard, Over-the-counter
Applicant Boyd Research, Inc. 5820 Bali Way S St. Pete Beach,  FL  33706
ContactJames Boyd
CorrespondentJames Boyd
Boyd Research, Inc. 5820 Bali Way S St. Pete Beach,  FL  33706
Product CodeOBR  
Subsequent Product CodeMQC
Subsequent Product CodeOCO
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2021-09-17

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