Cleared Special

CUSTOM COMFORT NIGHTGUARD VERSION 2

K091660 · Den Tek Oral Care, Inc. · Dental

Jun 2009

Decision

Days

—

Risk

About This 510(k) Submission

K091660 is an FDA 510(k) clearance for the CUSTOM COMFORT NIGHTGUARD VERSION 2, a Mouthguard, Over-the-counter, submitted by Den Tek Oral Care, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on June 12, 2009, 3 days after receiving the submission on June 9, 2009. This device falls under the Dental review panel.

Submission Details

510(k) Number	K091660 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2009
Decision Date	June 12, 2009
Days to Decision	3 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.