Cleared Special

K083400 - CUSTOM COMFORT NIGHTGUARD

K083400 · 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
Dec 2008
Decision
24d
Days
-
Risk

K083400 is an FDA 510(k) clearance for the CUSTOM COMFORT 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 December 11, 2008 after a review of 24 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 - K083400

510(k) Number K083400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date December 11, 2008
Days to Decision 24 days
Submission Type Special
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
104d faster than avg
Panel avg: 128d · This submission: 24d
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 K083400.
REST ASSURED GENERATION II DENTAL PROTECTOR
K091792 · Ranir Corporation · Jul 2009
CUSTOM COMFORT NIGHTGUARD VERSION 2
K091660 · Den Tek Oral Care, Inc. · Jun 2009
GRIND NO MORE VERSION 2 AND 3
K091175 · Ranir, LLC · May 2009
GRIND NO MORE
K082301 · Placontrol, Inc. · Oct 2008
IMPROVED COMFORT-FIT NIGHTGUARD
K081669 · Den Tek Oral Care, Inc. · Jul 2008
STRESSGARD NIGHTGUARD
K072968 · Totalgard Corporation · Jul 2008
K083400 · CUSTOM COMFORT NIGHTGUARD
Download PDF FDA Summary Den Tek Oral Care, In…