MQC
- Product code
- MQC
- Device name
- Mouthguard, Prescription
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 13 (direct download)
- 510(k) clearances (all years, FDA)
- 71 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253798 | 2026-03-02 | Guangzhou Heygears IMC., Inc. | UltraPrint-Dental Hard Splint UV | |
| K250743 | 2025-12-05 | Remvia | Remvia NightGuard | |
| K251252 | 2025-08-01 | Shandong Huge Dental Material Corporat… | NOBILCAM IMPAK Disc | |
| K241729 | 2025-03-18 | Whip Mix Corporation | Hard Splint & Thermo-Adaptive Splint | |
| K243516 | 2025-02-10 | Grindguard, Inc. | Remi Custom Night Guard | |
| K241369 | 2024-08-22 | Lijia, LLC | LIJIA Night Guard | |
| K231775 | 2024-08-08 | Pro3Dure Medical | GR Resin System MSI | |
| K241311 | 2024-08-02 | Bernhard Förster GmbH | Thermoforming Sheet Materials (Track A); Thermoformi… | |
| K240463 | 2024-06-04 | Slow Wave, Inc. | Slow Wave DS8 (SWDS802) | |
| K231793 | 2024-03-26 | Belport Company, Inc., Gingi-Pak | RODIN 3D Resin SPLINT, Hard/Flex | — |
| K232087 | 2024-02-16 | Formlabs Ohio, Inc. | Dental LT Comfort Resin | FDA |
| K230548 | 2024-02-02 | Myohealth Technologies, LLC | Myoaligner Appliance | |
| K230592 | 2024-01-18 | LuxCreo, Inc. | LuxCreo Dental Night Guard Resin | — |
| K222845 | 2023-11-28 | Frey Oral Technologies, LLC | Clench Relief Mouth Piece PRO RX, Clench Relief Mout… | |
| K230495 | 2023-10-13 | Meris Investment Group | Serena Sleep Night Guard | |
| K232448 | 2023-10-12 | Detax GmbH | FREEPRINT® splintmaster | |
| K230237 | 2023-09-14 | Hkable 3D Biologic Printing Technology… | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.6… | — |
Official FDA classification page: MQC
Classification and pathway per current FDA publications. Data from openFDA (CC0).