Cleared Special

DEN TEK COMFORT FIT NIGHTGUARD

K072147 · Den Tek Oral Care, Inc. · Dental
Aug 2007
Decision
27d
Days
—
Risk

About This 510(k) Submission

K072147 is an FDA 510(k) clearance for the DEN TEK 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 August 30, 2007, 27 days after receiving the submission on August 3, 2007. This device falls under the Dental review panel.

Submission Details

510(k) Number K072147 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2007
Decision Date August 30, 2007
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.