Cleared Abbreviated

K132469 - THE BITE GUARD (FDA 510(k) Clearance)

K132469 · International Profit Builders, Inc. · Dental device
Download Printable Device Report (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.

View all International Profit Builders, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 127d · This submission: 205d
Pathway characteristics
Standards-based clearance path.

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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