Cleared Special

IMPROVED COMFORT-FIT NIGHTGUARD

K081669 · Den Tek Oral Care, Inc. · Dental

Jul 2008

Decision

27d

Days

—

Risk

About This 510(k) Submission

K081669 is an FDA 510(k) clearance for the IMPROVED COMFORT-FIT NIGHTGUARD, a Mouthguard, Over-the-counter, submitted by Den Tek Oral Care, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on July 10, 2008, 27 days after receiving the submission on June 13, 2008. This device falls under the Dental review panel.

Submission Details

510(k) Number	K081669 FDA.gov
FDA Decision	Cleared 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

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.