Cleared Abbreviated

K132469 - THE BITE GUARD

K132469 · International Profit Builders, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
205d
Days
-
Risk

K132469 is an FDA 510(k) clearance for the THE BITE GUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by International Profit Builders, Inc. (Highland, US). The FDA issued a Cleared decision on February 28, 2014 after a review of 205 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K132469

510(k) Number K132469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date February 28, 2014
Days to Decision 205 days
Submission Type Abbreviated
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
77d slower than avg
Panel avg: 128d · This submission: 205d
Pathway characteristics
Standards-based clearance path.

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 K132469.
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GRINDGUARD
K133037 · Grind Guard Technologies, LLC · Jan 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
K132469 · THE BITE GUARD
Download PDF FDA Summary International Profit …