Cleared Traditional

K111310 - BRUX MOUTHGUARDS

K111310 · Dental Arte, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
212d
Days
-
Risk

K111310 is an FDA 510(k) clearance for the BRUX MOUTHGUARDS. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Dental Arte, Inc. (Braderdon, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 212 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.

FDA 510(k) Submission Details - K111310

510(k) Number K111310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2011
Decision Date December 08, 2011
Days to Decision 212 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
84d slower than avg
Panel avg: 128d · This submission: 212d
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 K111310.
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · Oralabs, Inc. · Jun 2012
REST ASSURED GENERATION III DENTAL PROTECTOR
K120103 · Ranir, LLC · Feb 2012
REST ASSURED READY TO WEAR NITE PROTECTOR
K112879 · Ranir, LLC · Jan 2012
SLEEPRIGHT
K100545 · Power Products, Inc.-Splintek · Jun 2010
GRIND NO MORE GENERATION II
K094020 · Ranir, LLC · Jan 2010
REST ASSURED GENERATION II DENTAL PROTECTOR
K091792 · Ranir Corporation · Jul 2009
K111310 · BRUX MOUTHGUARDS
Download PDF FDA Summary Dental Arte, Inc.