Product code MQC
- Device name
- Mouthguard, Prescription
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | 2026-03-02 |
| K250743 | Remvia NightGuard | Remvia | 2025-12-05 |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | 2025-08-01 |
| K241729 | Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation | 2025-03-18 |
| K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025-02-10 |
| K241369 | LIJIA Night Guard | Lijia, LLC | 2024-08-22 |
| K231775 | GR Resin System MSI | Pro3Dure Medical | 2024-08-08 |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) | Bernhard Förster GmbH | 2024-08-02 |
| K240463 | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | 2024-06-04 |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | 2024-02-16 |
| K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024-02-02 |
| K230592 | LuxCreo Dental Night Guard Resin | LuxCreo, Inc. | 2024-01-18 |
| K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | 2023-11-28 |
| K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023-10-13 |
| K232448 | FREEPRINT® splintmaster | Detax GmbH | 2023-10-12 |
| 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. | 2023-09-14 |
| K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S | Dentona AG | 2023-04-21 |
| K223798 | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | 2023-02-17 |
| K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022-11-10 |
| K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022-10-21 |
| K220894 | SmileGuard | Envisiontec GmbH | 2022-06-10 |
| K212017 | Thermeo System | Pro3Dure Medical GmbH | 2022-04-08 |
| K214102 | Glidewell Appliance Resin, Hard/Soft | Prismatik Dentalcraft, Inc. | 2022-02-23 |
| K212767 | SleepRight Select-Comfort Dental Guard | Splintek, Inc. | 2021-12-22 |
| K212448 | NightGuard Flex | Sprintray, Inc. | 2021-11-12 |
| K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021-10-21 |
| K210940 | LuxaPrint Ortho Plus | Dmg Digital Enterprises SE | 2021-09-03 |
| K210011 | JS Dental Lab Mouth Guard | Ampower Dental Laboratories, LLC | 2021-07-16 |
| K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021-04-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H66842000141 | KeyPrint | Keystone Industries | 2024-09-26 |
| H66841101411 | KeyPrint | Keystone Industries | 2023-09-25 |
| EPRCD1001501 | printodent GR-19.1 OA | pro3dure medical GmbH | 2023-08-29 |
| EPRCD1001504 | printodent GR-19.1 OA I MSI | pro3dure medical GmbH | 2023-08-29 |
| H66842001611 | KeyPrint | Keystone Industries | 2023-02-20 |
| H66842000111 | KeyPrint | Keystone Industries | 2023-02-20 |
| H668210061 | American Dental | Keystone Industries | 2022-11-30 |
| H668210051 | American Dental | Keystone Industries | 2022-11-30 |
| H668210041 | American Dental | Keystone Industries | 2022-11-30 |
| EPRC66077916 | dima Print Splint clear | pro3dure medical GmbH | 2021-11-25 |
| H66842200041 | KeyPrint | Keystone Industries | 2021-04-22 |
| H66842000041 | KeyPrint | Keystone Industries | 2021-04-22 |
| H66842200051 | KeyPrint | Keystone Industries | 2019-12-20 |
| 08435288449302 | IDODENTINE | UNION DENTAL SA | 2019-10-29 |
| 08435288449807 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288442983 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443423 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443430 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443447 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443461 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443492 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288449876 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288449869 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288449852 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288449821 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288449814 | IDODENTINE | UNION DENTAL SA | 2018-07-09 |
| 08435288443294 | IDODENTINE | UNION DENTAL SA | 2016-12-16 |
| 08435288442846 | IDODENTINE | UNION DENTAL SA | 2016-12-16 |
| 08435288442723 | IDODENTINE | UNION DENTAL SA | 2016-12-16 |
| 08435288442587 | IDODENTINE | UNION DENTAL SA | 2016-12-16 |