Cleared Traditional

K250456 - Dentemp Pro-Comfort Dental Guard

K250456 · Doc Brands, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
90d
Days
-
Risk

K250456 is an FDA 510(k) clearance for the Dentemp Pro-Comfort Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Doc Brands, Inc. (Wayne, US). The FDA issued a Cleared decision on May 19, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Doc Brands, Inc. devices

FDA 510(k) Submission Details - K250456

510(k) Number K250456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date May 19, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

OBR Device Classification - Class 0,

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 19
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K250456.
Owl Night Guard
K253641 · Owl Dental Lab, Inc. · Feb 2026
enCore Night Guard
K252004 · Encore Guards · Nov 2025
Remi Custom Night Guard
K251778 · Remi · Oct 2025
Anti Grinding Guard
K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024
Goyo Mouthpiece S
K232238 · Dimedikorea · Apr 2024
Mouth Guard (ATG0603R)
K231865 · Reazeal Corp · Nov 2023