Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQC — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
184 daysmedian FDA review time
323 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | 2026-03-02 | 94 | 0 |
| K250743 | Remvia NightGuard | Remvia | 2025-12-05 | 269 | 0 |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | 2025-08-01 | 100 | 0 |
| K241729 | Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation | 2025-03-18 | 277 | 0 |
| K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025-02-10 | 89 | 0 |
| K241369 | LIJIA Night Guard | Lijia, LLC | 2024-08-22 | 100 | 0 |
| K231775 | GR Resin System MSI | Pro3Dure Medical | 2024-08-08 | 419 | 0 |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet | Bernhard Förster GmbH | 2024-08-02 | 85 | 0 |
| K240463 | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | 2024-06-04 | 109 | 0 |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | 2024-03-26 | 280 | 0 |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | 2024-02-16 | 218 | 0 |
| K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024-02-02 | 339 | 0 |
| K230592 | LuxCreo Dental Night Guard Resin | LuxCreo, Inc. | 2024-01-18 | 321 | 0 |
| K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | 2023-11-28 | 433 | 0 |
| K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023-10-13 | 232 | 0 |
| K232448 | FREEPRINT® splintmaster | Detax GmbH | 2023-10-12 | 59 | 0 |
| K230237 | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0 | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | 2023-09-14 | 227 | 0 |
| K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, | Dentona AG | 2023-04-21 | 235 | 0 |
| K223798 | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | 2023-02-17 | 60 | 0 |
| K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022-11-10 | 120 | 0 |
| K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022-10-21 | 198 | 0 |
| K220894 | SmileGuard | Envisiontec GmbH | 2022-06-10 | 74 | 0 |
| K212017 | Thermeo System | Pro3Dure Medical GmbH | 2022-04-08 | 284 | 0 |
| K214102 | Glidewell Appliance Resin, Hard/Soft | Prismatik Dentalcraft, Inc. | 2022-02-23 | 56 | 0 |
| K212767 | SleepRight Select-Comfort Dental Guard | Splintek, Inc. | 2021-12-22 | 113 | 0 |
| K212448 | NightGuard Flex | Sprintray, Inc. | 2021-11-12 | 99 | 0 |
| K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021-10-21 | 168 | 0 |
| K210940 | LuxaPrint Ortho Plus | Dmg Digital Enterprises SE | 2021-09-03 | 158 | 0 |
| K210011 | JS Dental Lab Mouth Guard | Ampower Dental Laboratories, LLC | 2021-07-16 | 193 | 0 |
| K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021-04-20 | 132 | 0 |
| K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021-04-09 | 190 | 1 |
| K201173 | E-Guard | Envisiontec GmbH | 2020-11-27 | 210 | 0 |
| K202465 | Night Guard | 3D Diagnostix, Inc. | 2020-11-25 | 90 | 0 |
| K201091 | V-Print splint | Voco GmbH | 2020-11-06 | 197 | 0 |
| K200125 | Thermoforming Sheet Materials | Erkodent Erich Kopp GmbH | 2020-10-28 | 281 | 0 |
| K191836 | Ceramill A-Splint | Amann Girrbach AG | 2019-12-20 | 164 | 0 |
| K183598 | KeyPrint KeySplint Soft | Keystone Industries | 2019-11-15 | 324 | 0 |
| K182820 | The POD | Advanced Facialdontics, LLC | 2019-07-17 | 286 | 0 |
| K190107 | VeriSplint | Whip Mix Corporation | 2019-07-10 | 169 | 0 |
| K181361 | Brux Night Guard | Brux Night Guard | 2019-04-11 | 323 | 0 |
| K170985 | Urbanek Device | Tmj Services, LLC | 2017-09-25 | 175 | 0 |
| K161884 | Ortho System | 3Shape A/S | 2017-04-19 | 282 | 0 |
| K151933 | BRX PRO Bruxism Guard | 12th Man Technologies, Inc. | 2015-12-10 | 149 | 0 |
| K143655 | SICAT OPTIMOTION | Sicat GmbH & Co. KG | 2015-10-02 | 283 | 0 |
| K143623 | Narval Brux | Resmed Sas | 2015-08-13 | 234 | 0 |
| K134015 | M-PM-DISC | Merz Dental GmbH | 2014-04-11 | 105 | 0 |
| K123161 | SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGH | Smartguard, Inc. | 2013-03-14 | 156 | 0 |
| K121365 | THERMOFORMED MOUTHGUARDS | Glidewell Laboratories-Sleep Devices Group | 2012-11-20 | 197 | 0 |
| K112868 | DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, | Dreamgard, Inc. | 2012-01-19 | 111 | 0 |
| K102909 | SOMNOBRUX SPLINTS | Somnomed, Inc. | 2011-12-13 | 438 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda