Cleared Special

K123849 - NEW COMFORT-FIT DENTAL GUARD

K123849 · Den Tek Oral Care, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
27d
Days
-
Risk

K123849 is an FDA 510(k) clearance for the NEW COMFORT-FIT DENTAL GUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on January 10, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K123849

510(k) Number K123849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2012
Decision Date January 10, 2013
Days to Decision 27 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K123849.
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K113326 · Oralabs, Inc. · Jun 2012
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K120103 · Ranir, LLC · Feb 2012
K123849 · NEW COMFORT-FIT DENTAL GUARD
Download PDF FDA Summary Den Tek Oral Care, In…