Product code MQC · Class U
Mouthguard, Prescription
3510(k)s in 12 months (72 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pro3Dure Medical | 4 | 0 |
| Dental Concepts, LLC | 2 | 0 |
| Envisiontec GmbH | 2 | 0 |
| Formlabs Ohio, Inc. | 2 | 0 |
| Keystone Industries | 1 | 1 |
| Power Products, Inc.-Splintek | 2 | 0 |
| Prismatik Dentalcraft, Inc. | 2 | 0 |
| Whip Mix Corporation | 2 | 0 |
| 12th Man Technologies, Inc. | 1 | 0 |
| 3D Diagnostix, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2026 | K260031 | THERMEO® I MSI Pro3Dure Medical GmbH, DE | MQC |
| Mar 2, 2026 | K253798 | UltraPrint-Dental Hard Splint UV Guangzhou Heygears IMC., Inc., CN | MQC |
| Dec 5, 2025 | K250743 | Remvia NightGuard Remvia | MQC |
| Aug 1, 2025 | K251252 | NOBILCAM IMPAK Disc Shandong Huge Dental Material Corporation, CN | MQC |
| Mar 18, 2025 | K241729 | Hard Splint & Thermo-Adaptive Splint Whip Mix Corporation | MQC |
| Feb 10, 2025 | K243516 | Remi Custom Night Guard Grindguard, Inc. | MQC |
| Aug 22, 2024 | K241369 | LIJIA Night Guard Lijia, LLC | MQC |
| Aug 8, 2024 | K231775 | GR Resin System MSI Pro3Dure Medical, DE | MQC |
| Aug 2, 2024 | K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E Bernhard Förster GmbH, DE | MQC |
| Jun 4, 2024 | K240463 | Slow Wave DS8 (SWDS802) Slow Wave, Inc. | MQC |
| Mar 26, 2024 | K231793 | RODIN 3D Resin SPLINT, Hard/Flex Belport Company, Inc., Gingi-Pak | MQC |
| Feb 16, 2024 | K232087 | Dental LT Comfort Resin Formlabs Ohio, Inc. | MQC |
| Feb 2, 2024 | K230548 | Myoaligner Appliance Myohealth Technologies, LLC | MQC |
| Jan 18, 2024 | K230592 | LuxCreo Dental Night Guard Resin LuxCreo, Inc. | MQC |
| Nov 28, 2023 | K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece Frey Oral Technologies, LLC | MQC |
| Oct 13, 2023 | K230495 | Serena Sleep Night Guard Meris Investment Group | MQC |
| Oct 12, 2023 | K232448 | FREEPRINT® splintmaster Detax GmbH, DE | MQC |
| Sep 14, 2023 | 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. Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd., CN | MQC |
| Apr 21, 2023 | K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S Dentona AG, DE | MQC |
| Feb 17, 2023 | K223798 | Glidewell TuffSplint Appliance Resin Prismatik Dentalcraft, Inc. | MQC |
| Nov 10, 2022 | K222061 | Dental LT Clear V2 Resin Formlabs Ohio, Inc. | MQC |
| Oct 21, 2022 | K221022 | NextDent Ortho Flex Vertex-Dental B.V., NL | MQC |
| Jun 10, 2022 | K220894 | SmileGuard Envisiontec GmbH, DE | MQC |
| Apr 8, 2022 | K212017 | Thermeo System Pro3Dure Medical GmbH, DE | MQC |
| Feb 23, 2022 | K214102 | Glidewell Appliance Resin, Hard/Soft Prismatik Dentalcraft, Inc. | MQC |
| Dec 22, 2021 | K212767 | SleepRight Select-Comfort Dental Guard Splintek, Inc. | MQC |
| Nov 12, 2021 | K212448 | NightGuard Flex Sprintray, Inc. | MQC |
| Oct 21, 2021 | K211415 | GR Splint Resin System Pro3Dure Medical GmbH, DE | MQC |
| Sep 3, 2021 | K210940 | LuxaPrint Ortho Plus Dmg Digital Enterprises SE, DE | MQC |
| Jul 16, 2021 | K210011 | JS Dental Lab Mouth Guard Ampower Dental Laboratories, LLC | MQC |
| Apr 20, 2021 | K203596 | Panthera Occlusal Appliance Panthera Dental, Inc., CA | MQC |
| Apr 9, 2021 | K203000 | KeyPrint KeySplint Hard Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | MQC |
| Nov 27, 2020 | K201173 | E-Guard Envisiontec GmbH, DE | MQC |
| Nov 25, 2020 | K202465 | Night Guard 3D Diagnostix, Inc. | MQC |
| Nov 6, 2020 | K201091 | V-Print splint Voco GmbH, DE | MQC |
| Oct 28, 2020 | K200125 | Thermoforming Sheet Materials Erkodent Erich Kopp GmbH, DE | MQC |
| Dec 20, 2019 | K191836 | Ceramill A-Splint Amann Girrbach AG, AT | MQC |
| Nov 15, 2019 | K183598 | KeyPrint KeySplint Soft Keystone Industries | MQC |
| Jul 17, 2019 | K182820 | The POD Advanced Facialdontics, LLC | MQC |
| Jul 10, 2019 | K190107 | VeriSplint Whip Mix Corporation | MQC |
| Apr 11, 2019 | K181361 | Brux Night Guard Brux Night Guard | MQC |
| Sep 25, 2017 | K170985 | Urbanek Device Tmj Services, LLC | MQC |
| Apr 19, 2017 | K161884 | Ortho System 3Shape A/S, DK | MQC |
| Dec 10, 2015 | K151933 | BRX PRO Bruxism Guard 12th Man Technologies, Inc. | MQC |
| Oct 2, 2015 | K143655 | SICAT OPTIMOTION Sicat GmbH & Co. KG, DE | MQC |
| Aug 13, 2015 | K143623 | Narval Brux Resmed Sas, FR | MQC |
| Apr 11, 2014 | K134015 | M-PM-DISC Merz Dental GmbH | MQC |
| Mar 14, 2013 | K123161 | SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE Smartguard, Inc. | MQC |
| Nov 20, 2012 | K121365 | THERMOFORMED MOUTHGUARDS Glidewell Laboratories-Sleep Devices Group | MQC |
| Jan 19, 2012 | K112868 | DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX Dreamgard, Inc. | MQC |
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