MQC

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
Declining activity - 6 submissions in the last 2 years vs 15 in the prior period
Review times improving: avg 155d recently vs 193d historically

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 - 6 submissions in the last 24 months compared to 15 in the prior period.

FDA 510(k) Review Time - MQC Product Code

Recent submissions under MQC have taken an average of 155 days to reach a decision - down from 193 days historically, suggesting improved FDA processing for this classification.

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