Cleared Special

NEW COMFORT-FIT DENTAL GUARD

K123849 · Den Tek Oral Care, Inc. · Dental

Jan 2013

Decision

27d

Days

—

Risk

About This 510(k) Submission

K123849 is an FDA 510(k) clearance for the NEW COMFORT-FIT DENTAL GUARD, a Mouthguard, Over-the-counter, submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on January 10, 2013, 27 days after receiving the submission on December 14, 2012. This device falls under the Dental review panel.

Submission Details

510(k) Number	K123849 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2012
Decision Date	January 10, 2013
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.