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.
Cleared Devices (31)
| 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 |
| K133907 | VSP SYSTEM | Medical Modeling, Inc. | Jan 22, 2014 | SESE |
| K120956 | VSP SYSTEM | Medical Modeling, Inc. | Dec 12, 2012 | SESE |
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | Apr 1, 2004 | SESE |
| K943540 | SURGICAL CUTTING BURS | Stryker Corp. | Nov 30, 1994 | SESE |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | Sensor Medics Corp. | Oct 28, 1992 | SESE |
| K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT | Artech Corp. | Sep 27, 1989 | SESE |
| K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT | Artech Corp. | Sep 27, 1989 | SESE |
| K883922 | TECHMEDICA I.B.O. BLADE | Techmedica, Inc. | Dec 8, 1988 | SESE |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Military Engineering, Inc. | Jul 31, 1987 | SESE |
| K781974 | IMPLANT DRIVERS AND TIPS | Miter, Inc. | Dec 28, 1978 | SESE |
| K760960 | SURGICAL WIRE DRIVER | American Safety Equipment Corp. | Nov 19, 1976 | SESE |
Top Applicants
- Propel Orthodontics, LLC — 2 clearances
- Medical Modeling, Inc. — 2 clearances
- Medcad — 2 clearances
- KLS-Martin L.P. — 2 clearances
- Artech Corp. — 2 clearances
