Cleared Traditional

Protect-It Custom Fit Dental Guard (K222424) - FDA 510(k) Clearance

K222424 · Doc Brands, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
57d
Days
-
Risk

K222424 is an FDA 510(k) clearance for the Protect-It Custom Fit 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 October 7, 2022 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Doc Brands, Inc. devices

Submission Details

510(k) Number K222424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

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.

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 K222424.
Goyo Mouthpiece S
K232238 · Dimedikorea · Apr 2024
Mouth Guard (ATG0603R)
K231865 · Reazeal Corp · Nov 2023
FBCC Night Guard
K221369 · Fbcc, Inc. · Nov 2022
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K212706 · Splintek, Inc. · Dec 2021
NTI ClenchGuard
K211158 · Boyd Research, Inc. · Sep 2021
DenTek Fresh Protect Dental Guard
K202974 · Medtech Products, Inc. · Dec 2020