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510(k) K211158

Device
NTI ClenchGuard
Applicant
Boyd Research, Inc.
510(k) number
K211158
Product code
OBR  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-17
Date received
2021-04-19
Regulation
510(k) Premarket Notification
Classification name
Mouthguard, Over-the-counter
Medical specialty
510(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
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
James Boyd
Address
5820 Bali Way S St Pete Beach FL US 33706 33706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited2026-04-10
K253641Owl Night GuardOwl Dental Lab, Inc.2026-02-26
K252004enCore Night GuardEncore Guards2025-11-25
K251778Remi Custom Night GuardRemi2025-10-17
K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.2025-05-19
K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.2024-05-24
K232238Goyo Mouthpiece SDimedikorea2024-04-17
K231865Mouth Guard (ATG0603R)Reazeal Corp2023-11-06
K221369FBCC Night GuardFbcc, Inc.2022-11-18
K222424Protect-It Custom Fit Dental GuardDoc Brands, Inc.2022-10-07
K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.2021-12-13
K202974DenTek Fresh Protect Dental GuardMedtech Products, Inc.2020-12-22
K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.2020-06-01
K181005ClenchGuardBoyd Research, Inc.2020-01-15
K183315CustMBite Dental GuardDental Choice Holdings, LLC2019-08-23

Legacy Summary#

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FDA Review#

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