FDA Product Code MQC: Mouthguard, Prescription
Leading manufacturers include Envisiontec GmbH, Pro3dure Medical GmbH and Prismatik Dentalcraft, Inc..
71
Total
71
Cleared
190d
Avg days
1996
Since
71 devices
Cleared
Jan 19, 2012
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
Dreamgard, Inc.
Dental
111d
Cleared
Nov 22, 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
Migratherapy, LLC
Dental
218d
Cleared
Oct 26, 2011
CLEARSPLINT ES
Astron Dental Corporation
Dental
120d
Cleared
Aug 05, 2011
FREEWAY COMFORT BITE GUARD
Randmark Dental Products, LLC
Dental
169d
Cleared
Nov 16, 2007
THERMOFORM SHEET MATERIALS AND ACCESSORIES
Dentsply International, Inc.
Dental
70d
Cleared
Sep 17, 2003
PRIMOSPLINT SYSTEM
Cosmedent, Inc.
Dental
184d
Cleared
Oct 07, 1998
ACCU-BITE HOME KIT DISCLUDER
Jerome M. Simon
Dental
208d
Cleared
Jul 15, 1998
NTI CLENCHING SUPPRESSION SYSTEM
Heraeus Kulzer, Inc.
Dental
76d
Cleared
Mar 08, 1996
NIGHTGUARD DIAGNOSTIC APPLIANCE
Cycura Corp.
Dental
84d