Cleared Traditional

Protect-It Custom Fit Dental Guard

K222424 · Doc Brands, Inc. · Dental
Oct 2022
Decision
57d
Days
—
Risk

About This 510(k) Submission

K222424 is an FDA 510(k) clearance for the Protect-It Custom Fit Dental Guard, a Mouthguard, Over-the-counter, submitted by Doc Brands, Inc. (Wayne, US). The FDA issued a Cleared decision on October 7, 2022, 57 days after receiving the submission on August 11, 2022. This device falls under the Dental review panel.

Submission Details

510(k) Number K222424 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2022
Decision Date October 07, 2022
Days to Decision 57 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.