Cleared Traditional

Dentemp Pro-Comfort Dental Guard

K250456 · Doc Brands, Inc. · Dental
May 2025
Decision
90d
Days
—
Risk

About This 510(k) Submission

K250456 is an FDA 510(k) clearance for the Dentemp Pro-Comfort Dental Guard, a Mouthguard, Over-the-counter, submitted by Doc Brands, Inc. (Wayne, US). The FDA issued a Cleared decision on May 19, 2025, 90 days after receiving the submission on February 18, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number K250456 FDA.gov
FDA Decision Cleared 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

Device Classification

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.