Cleared Traditional

K113326 - ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD

K113326 · Oralabs, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
230d
Days
-
Risk

K113326 is an FDA 510(k) clearance for the ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Oralabs, Inc. (Parker, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 230 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 Oralabs, Inc. devices

FDA 510(k) Submission Details - K113326

510(k) Number K113326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2011
Decision Date June 27, 2012
Days to Decision 230 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
102d slower than avg
Panel avg: 128d · This submission: 230d
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
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