OBR

FDA Product Code OBR: Mouthguard, Over-the-counter

To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Leading manufacturers include Ranir, LLC, Den Tek Oral Care, Inc. and Splintek, Inc..

47

Total

47

Cleared

131d

Avg days

2006

Since

47 devices

25–47 of 47

Cleared Sep 30, 2015

Den Tek Oral Care, Inc.

Cleared Feb 28, 2014

International Profit Builders, Inc.

Cleared Jan 23, 2014

Grind Guard Technologies, LLC

Cleared Dec 20, 2013

REST ASSURED EXTRA COMFORT NITE PROTECTOR

Cleared Jan 10, 2013

NEW COMFORT-FIT DENTAL GUARD

Den Tek Oral Care, Inc.

Cleared Oct 15, 2012

Akervall Technologies, Inc.

Cleared Jun 27, 2012

ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD

Cleared Feb 03, 2012

REST ASSURED GENERATION III DENTAL PROTECTOR

Cleared Jan 27, 2012

REST ASSURED READY TO WEAR NITE PROTECTOR

Cleared Dec 08, 2011

BRUX MOUTHGUARDS

Dental Arte, Inc.

Cleared Jun 04, 2010

Power Products, Inc.-Splintek

Cleared Jan 25, 2010

GRIND NO MORE GENERATION II

Cleared Jul 08, 2009

REST ASSURED GENERATION II DENTAL PROTECTOR

Ranir Corporation

Cleared Jun 12, 2009

CUSTOM COMFORT NIGHTGUARD VERSION 2

Den Tek Oral Care, Inc.

Cleared May 08, 2009

GRIND NO MORE VERSION 2 AND 3

Cleared Dec 11, 2008

CUSTOM COMFORT NIGHTGUARD

Den Tek Oral Care, Inc.

Cleared Oct 06, 2008

Placontrol, Inc.

Cleared Jul 10, 2008

IMPROVED COMFORT-FIT NIGHTGUARD

Den Tek Oral Care, Inc.

Cleared Jul 01, 2008

STRESSGARD NIGHTGUARD

Totalgard Corporation

Cleared Feb 08, 2008

Cleared Dec 19, 2007

THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT

Prestige Brands, Inc.

Cleared Aug 30, 2007

DEN TEK COMFORT FIT NIGHTGUARD

Den Tek Oral Care, Inc.

Cleared Dec 19, 2006

REST ASSURED NITE PROTECTOR