Cleared Traditional

BRUX MOUTHGUARDS (K111310) - FDA 510(k) Clearance

K111310 · Dental Arte, Inc. · Dental device
Download Printable Device Report (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.

View all Dental Arte, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 127d · This submission: 212d
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 44
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