MQC

FDA Product Code MQC: Mouthguard, Prescription

Leading manufacturers include Pro3dure Medical GmbH, Prismatik Dentalcraft, Inc. and Formlabs Ohio, Inc..

71
Total
71
Cleared
190d
Avg days
1996
Since
Declining activity - 8 submissions in the last 2 years vs 13 in the prior period
Consistent review times: 179d avg (recent)

FDA 510(k) Cleared Mouthguard, Prescription Devices (Product Code MQC)

71 devices
1–24 of 71
Cleared Mar 02, 2026
UltraPrint-Dental Hard Splint UV
K253798
Guangzhou Heygears IMC., Inc.
Dental · 94d
Cleared Dec 05, 2025
Remvia NightGuard
K250743
Remvia
Dental · 269d
Cleared Aug 01, 2025
NOBILCAM IMPAK Disc
K251252
Shandong Huge Dental Material Corporation
Dental · 100d
Cleared Mar 18, 2025
Hard Splint & Thermo-Adaptive Splint
K241729
Whip Mix Corporation
Dental · 277d
Cleared Feb 10, 2025
Remi Custom Night Guard
K243516
Grindguard, Inc.
Dental · 89d
Cleared Aug 22, 2024
LIJIA Night Guard
K241369
Lijia, LLC
Dental · 100d
Cleared Aug 08, 2024
GR Resin System MSI
K231775
Pro3Dure Medical
Dental · 419d
Cleared Aug 02, 2024
Thermoforming Sheet Materials (Track A)
K241311
Bernhard F?rster GmbH
Dental · 85d
Cleared Jun 04, 2024
Slow Wave DS8 (SWDS802)
K240463
Slow Wave, Inc.
Dental · 109d
Cleared Mar 26, 2024
RODIN 3D Resin SPLINT, Hard/Flex
K231793
Belport Company, Inc., Gingi-Pak
Dental · 280d
Cleared Feb 16, 2024
Dental LT Comfort Resin
K232087
Formlabs Ohio, Inc.
Dental · 218d
Cleared Feb 02, 2024
Myoaligner Appliance
K230548
Myohealth Technologies, LLC
Dental · 339d
Cleared Jan 18, 2024
LuxCreo Dental Night Guard Resin
K230592
LuxCreo, Inc.
Dental · 321d
Cleared Nov 28, 2023
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K222845
Frey Oral Technologies, LLC
Dental · 433d
Cleared Oct 13, 2023
Serena Sleep Night Guard
K230495
Meris Investment Group
Dental · 232d
Cleared Oct 12, 2023
FREEPRINT® splintmaster
K232448
Detax GmbH
Dental · 59d
Cleared Sep 14, 2023
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
K230237
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Dental · 227d
Cleared Apr 21, 2023
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
K222604
Dentona AG
Dental · 235d
Cleared Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
K223798
Prismatik Dentalcraft, Inc.
Dental · 60d
Cleared Nov 10, 2022
Dental LT Clear V2 Resin
K222061
Formlabs Ohio, Inc.
Dental · 120d
Cleared Oct 21, 2022
NextDent Ortho Flex
K221022
Vertex-Dental B.V.
Dental · 198d
Cleared Jun 10, 2022
SmileGuard
K220894
Envisiontec GmbH
Dental · 74d
Cleared Apr 08, 2022
Thermeo System
K212017
Pro3dure Medical GmbH
Dental · 284d
Cleared Feb 23, 2022
Glidewell Appliance Resin, Hard/Soft
K214102
Prismatik Dentalcraft, Inc.
Dental · 56d

About Product Code MQC - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code MQC since 1996, with 71 receiving FDA clearance (average review time: 190 days).

Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 13 in the prior period.

FDA 510(k) Review Time - MQC Product Code

FDA review times for MQC submissions have been consistent, averaging 179 days recently vs 191 days historically.

MQC devices are reviewed by the Dental panel. Browse all Dental devices →