DZJ · Driver, Wire, And Bone Drill, Manual
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | DZJ |
|---|---|
| Device Name | Driver, Wire, And Bone Drill, Manual |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | Feb 21, 2025 | SESE |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | Dec 11, 2024 | SESE |
| K231520 | tmCMF Solution | Techmah Cmf | Oct 2, 2023 | SESE |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | Jun 23, 2023 | SESE |
| K223024 | MedCAD AccuPlan System | Medcad | Mar 7, 2023 | SESE |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | Sep 30, 2022 | SESE |
| K220648 | OMF ASP System | Vha Dean | Aug 11, 2022 | SESE |
| K212570 | OsteoPlan System | Osteomed, LLC | Feb 11, 2022 | SESE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | Jun 28, 2021 | SESE |
| K193301 | coDiagnostiX | Dental Wings GmbH | Jun 21, 2021 | SESE |
| K210347 | VSP System | 3D Systems | Apr 26, 2021 | SESE |
| K193499 | DigiGuide System | Protomed, Inc. | Nov 4, 2020 | SESE |
| K192282 | MedCAD® AccuPlan® System | Medcad | Oct 29, 2020 | SESE |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | Jun 9, 2020 | SESE |
| K192192 | VSP System | 3D Systems | Feb 26, 2020 | SESE |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Mar 11, 2019 | SESE |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Sep 13, 2018 | SESE |
| K172164 | PROPEL Device | Propel Orthodontics, LLC | Jan 17, 2018 | SESE |
| K150392 | PROPEL device | Propel Orthodontics, LLC | Sep 18, 2015 | SESE |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | Jun 23, 2015 | SESE |
Top Applicants
- 3D Systems — 2 clearances
- Artech Corp. — 2 clearances
- KLS-Martin L.P. — 2 clearances
- Medcad — 2 clearances
- Medical Modeling, Inc. — 2 clearances
