MQC · Mouthguard, Prescription
· Class U
Overview
| Product Code | MQC |
|---|---|
| Device Name | Mouthguard, Prescription |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | Mar 2, 2026 | SESE |
| K250743 | Remvia NightGuard | Remvia | Dec 5, 2025 | SESE |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | Aug 1, 2025 | SESE |
| K241729 | Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation | Mar 18, 2025 | SESE |
| K243516 | Remi Custom Night Guard | Grindguard, Inc. | Feb 10, 2025 | SESE |
| K241369 | LIJIA Night Guard | Lijia, LLC | Aug 22, 2024 | SESE |
| K231775 | GR Resin System MSI | Pro3Dure Medical | Aug 8, 2024 | SESE |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) | Bernhard Förster GmbH | Aug 2, 2024 | SESE |
| K240463 | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | Jun 4, 2024 | SESE |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | Mar 26, 2024 | SESE |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | Feb 16, 2024 | SESE |
| K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | Feb 2, 2024 | SESE |
| K230592 | LuxCreo Dental Night Guard Resin | LuxCreo, Inc. | Jan 18, 2024 | SESE |
| K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | Nov 28, 2023 | SESE |
| K230495 | Serena Sleep Night Guard | Meris Investment Group | Oct 13, 2023 | SESE |
| K232448 | FREEPRINT® splintmaster | Detax GmbH | Oct 12, 2023 | SESE |
| K230237 | 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) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | Sep 14, 2023 | SESE |
| K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S | Dentona AG | Apr 21, 2023 | SESE |
| K223798 | Glidewell TuffSplint Appliance Resin | Prismatik Dentalcraft, Inc. | Feb 17, 2023 | SESE |
| K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | Nov 10, 2022 | SESE |
Top Applicants
- Dental Concepts, LLC — 2 clearances
- Envisiontec GmbH — 2 clearances
- Formlabs Ohio, Inc. — 2 clearances
- Power Products, Inc.-Splintek — 2 clearances
- Prismatik Dentalcraft, Inc. — 2 clearances
