Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DZJ — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
142 daysmedian FDA review time
403 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026-06-03 | 2 | 0 |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillo | Materialise NV | 2025-02-21 | 88 | 0 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | 2024-12-11 | 132 | 0 |
| K231520 | tmCMF Solution | Techmah Cmf | 2023-10-02 | 130 | 0 |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023-06-23 | 142 | 0 |
| K223024 | MedCAD AccuPlan System | Medcad | 2023-03-07 | 159 | 0 |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | 2022-09-30 | 234 | 0 |
| K220648 | OMF ASP System | Vha Dean | 2022-08-11 | 157 | 0 |
| K212570 | OsteoPlan System | Osteomed, LLC | 2022-02-11 | 179 | 0 |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) S | Centermed, Inc. | 2021-06-28 | 403 | 0 |
| K193301 | coDiagnostiX | Dental Wings GmbH | 2021-06-21 | 570 | 0 |
| K210347 | VSP System | 3D Systems | 2021-04-26 | 77 | 0 |
| K193499 | DigiGuide System | Protomed, Inc. | 2020-11-04 | 323 | 0 |
| K192282 | MedCAD® AccuPlan® System | Medcad | 2020-10-29 | 434 | 0 |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | 2020-06-09 | 704 | 0 |
| K192192 | VSP System | 3D Systems | 2020-02-26 | 197 | 0 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2019-03-11 | 161 | 0 |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2018-09-13 | 126 | 0 |
| K172164 | PROPEL Device | Propel Orthodontics, LLC | 2018-01-17 | 183 | 0 |
| K150392 | PROPEL device | Propel Orthodontics, LLC | 2015-09-18 | 212 | 0 |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 2015-06-23 | 89 | 0 |
| K133907 | VSP SYSTEM | Medical Modeling, Inc. | 2014-01-22 | 30 | 0 |
| K120956 | VSP SYSTEM | Medical Modeling, Inc. | 2012-12-12 | 257 | 0 |
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-04-01 | 48 | 8 |
| K943540 | SURGICAL CUTTING BURS | Stryker Corp. | 1994-11-30 | 131 | 1 |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | Sensor Medics Corp. | 1992-10-28 | 307 | 0 |
| K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 | 105 | 0 |
| K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 | 105 | 0 |
| K883922 | TECHMEDICA I.B.O. BLADE | Techmedica, Inc. | 1988-12-08 | 83 | 0 |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Military Engineering, Inc. | 1987-07-31 | 80 | 0 |
| K781974 | IMPLANT DRIVERS AND TIPS | Miter, Inc. | 1978-12-28 | 31 | 0 |
| K760960 | SURGICAL WIRE DRIVER | American Safety Equipment Corp. | 1976-11-19 | 18 | 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