FDA.reportPublic FDA data

510(k) K250456

Device
Dentemp Pro-Comfort Dental Guard
Applicant
Doc Brands, Inc.
510(k) number
K250456
Product code
OBR
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-19
Date received
2025-02-18
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
N

Applicant Contact#

Contact
Sean Stubbs
Address
407 E. Lancaster Ave. Wayne PA US 19087 19087

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
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
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
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