MQC — Mouthguard, Prescription Class U
FDA Device Classification
Classification Details
- Product Code
- MQC
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253798 | guangzhou heygears imc | UltraPrint-Dental Hard Splint UV | March 2, 2026 |
| K250743 | remvia | Remvia NightGuard | December 5, 2025 |
| K251252 | shandong huge dental material corporation | NOBILCAM IMPAK Disc | August 1, 2025 |
| K241729 | whip mix corporation | Hard Splint & Thermo-Adaptive Splint | March 18, 2025 |
| K243516 | grindguard | Remi Custom Night Guard | February 10, 2025 |
| K241369 | lijia | LIJIA Night Guard | August 22, 2024 |
| K231775 | pro3dure medical | GR Resin System MSI | August 8, 2024 |
| K241311 | bernhard förster | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B) | August 2, 2024 |
| K240463 | slow wave | Slow Wave DS8 (SWDS802) | June 4, 2024 |
| K231793 | belport company, inc., gingi-pak | RODIN 3D Resin SPLINT, Hard/Flex | March 26, 2024 |
| K232087 | formlabs ohio | Dental LT Comfort Resin | February 16, 2024 |
| K230548 | myohealth technologies | Myoaligner Appliance | February 2, 2024 |
| K230592 | luxcreo | LuxCreo Dental Night Guard Resin | January 18, 2024 |
| K222845 | frey oral technologies | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | November 28, 2023 |
| K230495 | meris investment group | Serena Sleep Night Guard | October 13, 2023 |
| K232448 | detax | FREEPRINT® splintmaster | October 12, 2023 |
| K230237 | hkable 3d biologic printing technology(chongqing) co | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, H | September 14, 2023 |
| K222604 | dentona | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint | April 21, 2023 |
| K223798 | prismatik dentalcraft | Glidewell TuffSplint Appliance Resin | February 17, 2023 |
| K222061 | formlabs ohio | Dental LT Clear V2 Resin | November 10, 2022 |