FDA Product Code
FDA Product Code DZJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4120
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026-06-03 | Traditional | PDF ↗ |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025-02-21 | Traditional | PDF ↗ |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | 2024-12-11 | Traditional | PDF ↗ |
| K231520 | tmCMF Solution | Techmah Cmf | 2023-10-02 | Traditional | PDF ↗ |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023-06-23 | Traditional | PDF ↗ |
| K223024 | MedCAD AccuPlan System | Medcad | 2023-03-07 | Traditional | PDF ↗ |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K220648 | OMF ASP System | Vha Dean | 2022-08-11 | Traditional | PDF ↗ |
| K212570 | OsteoPlan System | Osteomed, LLC | 2022-02-11 | Traditional | PDF ↗ |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021-06-28 | Traditional | PDF ↗ |
| K193301 | coDiagnostiX | Dental Wings GmbH | 2021-06-21 | Traditional | PDF ↗ |
| K210347 | VSP System | 3D Systems | 2021-04-26 | Traditional | PDF ↗ |
| K193499 | DigiGuide System | Protomed, Inc. | 2020-11-04 | Traditional | PDF ↗ |
| K192282 | MedCAD® AccuPlan® System | Medcad | 2020-10-29 | Traditional | PDF ↗ |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | 2020-06-09 | Traditional | PDF ↗ |
| K192192 | VSP System | 3D Systems | 2020-02-26 | Traditional | PDF ↗ |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019-03-11 | Traditional | PDF ↗ |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018-09-13 | Traditional | PDF ↗ |
| K172164 | PROPEL Device | Propel Orthodontics, LLC | 2018-01-17 | Traditional | PDF ↗ |
| K150392 | PROPEL device | Propel Orthodontics, LLC | 2015-09-18 | Traditional | PDF ↗ |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 2015-06-23 | Traditional | PDF ↗ |
| K133907 | VSP SYSTEM | Medical Modeling, Inc. | 2014-01-22 | Special | PDF ↗ |
| K120956 | VSP SYSTEM | Medical Modeling, Inc. | 2012-12-12 | Traditional | PDF ↗ |
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-04-01 | Traditional | PDF ↗ |
| K943540 | SURGICAL CUTTING BURS | Stryker Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | Sensor Medics Corp. | 1992-10-28 | Traditional | PDF ↗ |
| K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 | Traditional | PDF ↗ |
| K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 | Traditional | PDF ↗ |
| K883922 | TECHMEDICA I.B.O. BLADE | Techmedica, Inc. | 1988-12-08 | Traditional | PDF ↗ |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Military Engineering, Inc. | 1987-07-31 | Traditional | PDF ↗ |
| K781974 | IMPLANT DRIVERS AND TIPS | Miter, Inc. | 1978-12-28 | Traditional | PDF ↗ |
| K760960 | SURGICAL WIRE DRIVER | American Safety Equipment Corp. | 1976-11-19 | Traditional | PDF ↗ |
Product code DZJ · Class II · Dental. Data: openFDA.