Cleared Traditional

CustMBite Dental Guard (K183315) - FDA 510(k) Clearance

K183315 · Dental Choice Holdings, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
266d
Days
-
Risk

K183315 is an FDA 510(k) clearance for the CustMBite Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Dental Choice Holdings, LLC (Louisville, US). The FDA issued a Cleared decision on August 23, 2019 after a review of 266 days - an extended review 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: 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 Dental Choice Holdings, LLC devices

Submission Details

510(k) Number K183315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2018
Decision Date August 23, 2019
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 Consultant

Smith Associates
E.J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K183315.
DenTek Fresh Protect Dental Guard
K202974 · Medtech Products, Inc. · Dec 2020
SleepRight ProRx Custom Dental Guard
K193577 · Splintek, Inc. · Jun 2020
ClenchGuard
K181005 · Boyd Research, Inc. · Jan 2020
LunaGuard Nighttime Dental Protector
K191033 · Mckeon Products · Aug 2019
Bright Guard
K181099 · Koncept Innovators, LLC · Jan 2019
DenTek Ultimate Dental Guard
K180933 · Medtech Products, Inc. · Sep 2018