FDA.reportPublic FDA data

510(k) K253641

Device
Owl Night Guard
Applicant
Owl Dental Lab, Inc.
510(k) number
K253641
Product code
OBR
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-26
Date received
2025-11-19
Classification name
Mouthguard, Over-The-Counter
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jason Huang
Address
345 Estudillo Ave. 211 San Leandro CA US 94577 94577

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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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
K211158NTI ClenchGuardBoyd Research, Inc.2021-09-17
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