Cleared Special

K081669 - IMPROVED COMFORT-FIT NIGHTGUARD

K081669 · Den Tek Oral Care, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
27d
Days
-
Risk

K081669 is an FDA 510(k) clearance for the IMPROVED COMFORT-FIT NIGHTGUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Den Tek Oral Care, Inc. (Washington, US). The FDA issued a Cleared decision on July 10, 2008 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.

View all Den Tek Oral Care, Inc. devices

FDA 510(k) Submission Details - K081669

510(k) Number K081669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2008
Decision Date July 10, 2008
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
100d faster than avg
Panel avg: 127d · 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.