Driver, Wire, And Bone Drill, Manual
FDA product code DZJ · Class II (moderate risk) · 21 CFR 872.4120 · Dental
32510(k) clearances
0PMA approvals
7recalls
Manufacturers
- 3D Systems, Inc. 3
- Propel Orthodontics, LLC 2
- Techfit Digital Surgery, Inc. 2
- Medcad 2
- KLS-Martin L.P. 2
- Medical Modeling, Inc. 2
- Artech Corp. 2
- Stryker Corporation 1
- Stryker Instruments 1
- Sensor Medics Corp. 1
- Synthes (USA) Products LLC 1
- American Safety Equipment Corp. 1
- Techmedica, Inc. 1
- Immersivetouch 1
- Military Engineering, Inc. 1
- Protomed, Inc. 1
- Dental Wings GmbH 1
- Centermed, Inc. 1
- Osteomed LP 1
- Materialise NV 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | Materialise NV | 02/21/2025SE |
| K242263 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery, Inc. | 12/11/2024SE |
| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
| K193301 | coDiagnostiXDZJ · Traditional | Dental Wings GmbH | 06/21/2021SE |
| K210347 | VSP SystemDZJ · Traditional | 3D Systems | 04/26/2021SE |
| K193499 | DigiGuide SystemDZJ · Traditional | Protomed, Inc. | 11/04/2020SE |
| K192282 | MedCAD® AccuPlan® SystemDZJ · Traditional | Medcad | 10/29/2020SE |
| K181813 | ImmersiveView Surgical Plan (IVSP®)DZJ · Traditional | Immersivetouch | 06/09/2020SE |
| K192192 | VSP SystemDZJ · Traditional | 3D Systems | 02/26/2020SE |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ · Traditional | KLS-Martin L.P. | 03/11/2019SE |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ · Traditional | KLS-Martin L.P. | 09/13/2018SE |
| K172164 | PROPEL DeviceDZJ · Traditional | Propel Orthodontics, LLC | 01/17/2018SE |
| K150392 | PROPEL deviceDZJ · Traditional | Propel Orthodontics, LLC | 09/18/2015SE |
| K150796 | Dental Bone Cutting InstrumentsDZJ · Traditional | Synthes (USA) Products, LLC | 06/23/2015SE |
| K133907 | VSP SystemDZJ · Special | Medical Modeling, Inc. | 01/22/2014SE |
| K120956 | VSP SystemDZJ · Traditional | Medical Modeling, Inc. | 12/12/2012SE |
| K040369 | Stryker Consolidated Operating Room Equipment (Core) SystemDZJ · Traditional | Stryker Instruments | 04/01/2004SE |
| K943540 | Surgical Cutting BursDZJ · Traditional | Stryker Corp. | 11/30/1994SE |
| K915848 | Sensormedics Model 2450 Pulmonary Function Lab.DZJ · Traditional | Sensor Medics Corp. | 10/28/1992SE |
| K894151 | Irrigated Drill for SS Submerged Screw PlantDZJ · Traditional | Artech Corp. | 09/27/1989SE |
| K894150 | Counterbore for SS Submerged Screw PlantDZJ · Traditional | Artech Corp. | 09/27/1989SE |
| K883922 | Techmedica I.B.O. BladeDZJ · Traditional | Techmedica, Inc. | 12/08/1988SE |
| K871834 | Drill, Hand, Bone, SmedbergDZJ · Traditional | Military Engineering, Inc. | 07/31/1987SE |
| K781974 | Implant Drivers and TipsDZJ · Traditional | Miter, Inc. | 12/28/1978SE |
| K760960 | Surgical Wire DriverDZJ · Traditional | American Safety Equipment Corp. | 11/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1510-2022 Class II | 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide…Scapula Marking Guide (anatomically Shaped) was incorrectly designed. | Medical Modeling, Inc. | 05/17/2022Open, Classified |
| Z-0092-2014 Class II | REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution…It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing… | Stryker Instruments Div. of Stryker… | 10/02/2013Terminated |
| Z-0199-2012 | Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | Stryker Instruments Div. of Stryker… | 10/18/2011Terminated |
| Z-0198-2012 | Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | Stryker Instruments Div. of Stryker… | 10/18/2011Terminated |
| Z-0197-2012 | Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | Stryker Instruments Div. of Stryker… | 10/18/2011Terminated |
| Z-0196-2012 | IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | Stryker Instruments Div. of Stryker… | 10/18/2011Terminated |
| Z-0195-2012 | IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | Stryker Instruments Div. of Stryker… | 10/18/2011Terminated |