MQC

FDA Product Code MQC: Mouthguard, Prescription

Leading manufacturers include Formlabs Ohio, Inc., Whip Mix Corporation and Envisiontec GmbH.

71
Total
71
Cleared
190d
Avg days
1996
Since
71 devices
25–48 of 71
Cleared Dec 22, 2021
SleepRight Select-Comfort Dental Guard
K212767
Splintek, Inc.
Dental · 113d
Cleared Nov 12, 2021
NightGuard Flex
K212448
Sprintray, Inc.
Dental · 99d
Cleared Oct 21, 2021
GR Splint Resin System
K211415
Pro3dure Medical GmbH
Dental · 168d
Cleared Sep 03, 2021
LuxaPrint Ortho Plus
K210940
Dmg Digital Enterprises SE
Dental · 158d
Cleared Jul 16, 2021
JS Dental Lab Mouth Guard
K210011
Ampower Dental Laboratories, LLC
Dental · 193d
Cleared Apr 20, 2021
Panthera Occlusal Appliance
K203596
Panthera Dental, Inc.
Dental · 132d
Cleared Apr 09, 2021
KeyPrint KeySplint Hard
K203000
Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
Dental · 190d
Cleared Nov 27, 2020
E-Guard
K201173
Envisiontec GmbH
Dental · 210d
Cleared Nov 25, 2020
Night Guard
K202465
3D Diagnostix, Inc.
Dental · 90d
Cleared Nov 06, 2020
V-Print splint
K201091
Voco GmbH
Dental · 197d
Cleared Oct 28, 2020
Thermoforming Sheet Materials
K200125
Erkodent Erich Kopp GmbH
Dental · 281d
Cleared Dec 20, 2019
Ceramill A-Splint
K191836
Amann Girrbach AG
Dental · 164d
Cleared Nov 15, 2019
KeyPrint KeySplint Soft
K183598
Keystone Industries
Dental · 324d
Cleared Jul 17, 2019
The POD
K182820
Advanced Facialdontics, LLC
Dental · 286d
Cleared Jul 10, 2019
VeriSplint
K190107
Whip Mix Corporation
Dental · 169d
Cleared Apr 11, 2019
Brux Night Guard
K181361
Brux Night Guard
Dental · 323d
Cleared Sep 25, 2017
Urbanek Device
K170985
Tmj Services, LLC
Dental · 175d
Cleared Apr 19, 2017
Ortho System
K161884
3Shape A/S
Dental · 282d
Cleared Dec 10, 2015
BRX PRO Bruxism Guard
K151933
12th Man Technologies, Inc.
Dental · 149d
Cleared Oct 02, 2015
SICAT OPTIMOTION
K143655
Sicat GmbH & Co. KG
Dental · 283d
Cleared Aug 13, 2015
Narval Brux
K143623
Resmed Sas
Dental · 234d
Cleared Apr 11, 2014
M-PM-DISC
K134015
Merz Dental GmbH
Dental · 105d
Cleared Mar 14, 2013
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
K123161
Smartguard, Inc.
Dental · 156d
Cleared Nov 20, 2012
THERMOFORMED MOUTHGUARDS
K121365
Glidewell Laboratories-Sleep Devices Group
Dental · 197d