Cleared Traditional

K133037 - GRINDGUARD

K133037 · Grind Guard Technologies, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
119d
Days
-
Risk

K133037 is an FDA 510(k) clearance for the GRINDGUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Grind Guard Technologies, LLC (Leola, US). The FDA issued a Cleared decision on January 23, 2014 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K133037

510(k) Number K133037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date January 23, 2014
Days to Decision 119 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
9d faster than avg
Panel avg: 128d · This submission: 119d
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 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 K133037.
Ora-GUARD Dental Grind Guard
K150492 · Bite Tech, Inc. · Feb 2016
Ready-Fit
K151149 · Den Tek Oral Care, Inc. · Sep 2015
THE BITE GUARD
K132469 · International Profit Builders, Inc. · Feb 2014
REST ASSURED EXTRA COMFORT NITE PROTECTOR
K133423 · Ranir, LLC · Dec 2013
NEW COMFORT-FIT DENTAL GUARD
K123849 · Den Tek Oral Care, Inc. · Jan 2013
PROTECH DENT
K121272 · Akervall Technologies, Inc. · Oct 2012
K133037 · GRINDGUARD
Download PDF FDA Summary Grind Guard Technolog…