FDA.reportPublic FDA data

510(k) K252004

Device
enCore Night Guard
Applicant
Encore Guards
510(k) number
K252004
Product code
OBR
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-25
Date received
2025-06-27
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
Benjamin Li
Address
1520 Brookhollow Dr. Unit 38 Santa Ana CA US 92705 92705

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
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K251778Remi Custom Night GuardRemi2025-10-17
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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