Cleared Traditional

K150492 - Ora-GUARD Dental Grind Guard

K150492 · Bite Tech, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
359d
Days
-
Risk

K150492 is an FDA 510(k) clearance for the Ora-GUARD Dental Grind Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Bite Tech, Inc. (Norwalk, US). The FDA issued a Cleared decision on February 19, 2016 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K150492

510(k) Number K150492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2015
Decision Date February 19, 2016
Days to Decision 359 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
231d slower than avg
Panel avg: 128d · This submission: 359d
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 Consultant

Hyman, Phelps & McNamara, P.C.
Alex Varond

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 46
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K150492.
DenTek Ultimate Dental Guard
K180933 · Medtech Products, Inc. · Sep 2018
Bruxor
K172452 · Sleep Specialties, LLC · Jan 2018
SleepRight ProRx Custom Dental Guard
K172223 · Splintek, Inc. · Nov 2017
Ready-Fit
K151149 · Den Tek Oral Care, Inc. · Sep 2015
THE BITE GUARD
K132469 · International Profit Builders, Inc. · Feb 2014
GRINDGUARD
K133037 · Grind Guard Technologies, LLC · Jan 2014
K150492 · Ora-GUARD Dental Grind Guard
Download PDF FDA Summary Bite Tech, Inc.