Cleared Special

CUSTOM COMFORT NIGHTGUARD

K083400 · Den Tek Oral Care, Inc. · Dental

Dec 2008

Decision

24d

Days

—

Risk

About This 510(k) Submission

K083400 is an FDA 510(k) clearance for the CUSTOM COMFORT NIGHTGUARD, a Mouthguard, Over-the-counter, submitted by Den Tek Oral Care, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on December 11, 2008, 24 days after receiving the submission on November 17, 2008. This device falls under the Dental review panel.

Submission Details

510(k) Number	K083400 FDA.gov
FDA Decision	Cleared 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

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.