MQC

FDA Product Code MQC: Mouthguard, Prescription

Leading manufacturers include Pro3dure Medical GmbH, Envisiontec GmbH and Power Products, Inc.-Splintek.

72
Total
72
Cleared
191d
Avg days
1996
Since
72 devices
49–72 of 72
Cleared Nov 20, 2012
THERMOFORMED MOUTHGUARDS
K121365
Glidewell Laboratories-Sleep Devices Group
Dental · 197d
Cleared Jan 19, 2012
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
K112868
Dreamgard, Inc.
Dental · 111d
Cleared Dec 13, 2011
SOMNOBRUX SPLINTS
K102909
Somnomed, Inc.
Dental · 438d
Cleared Nov 22, 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
K111066
Migratherapy, LLC
Dental · 218d
Cleared Oct 26, 2011
CLEARSPLINT ES
K111828
Astron Dental Corporation
Dental · 120d
Cleared Aug 05, 2011
FREEWAY COMFORT BITE GUARD
K110468
Randmark Dental Products, LLC
Dental · 169d
Cleared Feb 24, 2010
CLAYTON INTRA-AURAL DEVICE (CID)
K091880
Ascentia Health Incorporated
Dental · 245d
Cleared Oct 14, 2009
GRIND GUARD
K090472
Archtek, Inc.
Dental · 232d
Cleared Aug 31, 2009
GRINDGUARD
K082723
Grind Guard Technologies, LLC
Dental · 348d
Cleared Nov 16, 2007
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K072522
Dentsply International, Inc.
Dental · 70d
Cleared Aug 17, 2007
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
K071404
Power Products, Inc.-Splintek
Dental · 88d
Cleared Mar 12, 2007
NIGHT GUARD
K061122
Alpine Oral Care, LLC
Dental · 322d
Cleared Jan 23, 2007
DEN TEK NIGHTGUARD
K063483
Den Tek Oral Care, Inc.
Dental · 67d
Cleared Nov 27, 2006
MOUTHGUARD AND ALIGNER MATERIALS
K062828
Dentsply Intl., Inc.
Dental · 68d
Cleared Mar 03, 2006
DOCTOR'S NIGHTGUARD
K053580
Dental Concepts, LLC
Dental · 71d
Cleared Aug 27, 2004
MYOHEALTH CLENCHING INHIBITOR
K040315
Mci-Myohealth Systems
Dental · 200d
Cleared Oct 17, 2003
EZ SPLINT & EZ SPLINT PM
K022809
Power Products, Inc.-Splintek
Dental · 420d
Cleared Sep 17, 2003
PRIMOSPLINT SYSTEM
K030832
Cosmedent, Inc.
Dental · 184d
Cleared Mar 26, 2003
DENTAL PROTECTOR
K024261
Dental Concepts, LLC
Dental · 93d
Cleared Mar 18, 2003
DSG RELAXER SPLINT
K022627
Sentage Corporation D/B/A/ Dental Services Group
Dental · 223d
Cleared Feb 22, 2002
DR. HAYS BITE GUARD
K014079
Inventive Resources, Inc.
Dental · 73d
Cleared Oct 07, 1998
ACCU-BITE HOME KIT DISCLUDER
K980953
Jerome M. Simon
Dental · 208d
Cleared Jul 15, 1998
NTI CLENCHING SUPPRESSION SYSTEM
K981546
Heraeus Kulzer, Inc.
Dental · 76d
Cleared Mar 08, 1996
NIGHTGUARD DIAGNOSTIC APPLIANCE
K955701
Cycura Corp.
Dental · 84d