Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120) → DZJ — Driver, Wire, And Bone Drill, Manual # DZJ · Driver, Wire, And Bone Drill, Manual _Dental · 21 CFR 872.4120 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ ## Overview - **Product Code:** DZJ - **Device Name:** Driver, Wire, And Bone Drill, Manual - **Regulation:** [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K243637.md) | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | Feb 21, 2025 | SESE | | [K242263](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K242263.md) | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | Dec 11, 2024 | SESE | | [K231520](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K231520.md) | tmCMF Solution | Techmah Cmf | Oct 2, 2023 | SESE | | [K230276](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K230276.md) | TECHFIT DISRP® System | Techfit Digital Surgery | Jun 23, 2023 | SESE | | [K223024](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K223024.md) | MedCAD AccuPlan System | Medcad | Mar 7, 2023 | SESE | | [K220366](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K220366.md) | EmbedMed | 3D Lifeprints UK , Ltd. | Sep 30, 2022 | SESE | | [K220648](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K220648.md) | OMF ASP System | Vha Dean | Aug 11, 2022 | SESE | | [K212570](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K212570.md) | OsteoPlan System | Osteomed, LLC | Feb 11, 2022 | SESE | | [K201353](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K201353.md) | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | Jun 28, 2021 | SESE | | [K193301](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K193301.md) | coDiagnostiX | Dental Wings GmbH | Jun 21, 2021 | SESE | | [K210347](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K210347.md) | VSP System | 3D Systems | Apr 26, 2021 | SESE | | [K193499](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K193499.md) | DigiGuide System | Protomed, Inc. | Nov 4, 2020 | SESE | | [K192282](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K192282.md) | MedCAD® AccuPlan® System | Medcad | Oct 29, 2020 | SESE | | [K181813](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K181813.md) | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | Jun 9, 2020 | SESE | | [K192192](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K192192.md) | VSP System | 3D Systems | Feb 26, 2020 | SESE | | [K182789](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K182789.md) | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Mar 11, 2019 | SESE | | [K181241](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K181241.md) | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Sep 13, 2018 | SESE | | [K172164](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K172164.md) | PROPEL Device | Propel Orthodontics, LLC | Jan 17, 2018 | SESE | | [K150392](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K150392.md) | PROPEL device | Propel Orthodontics, LLC | Sep 18, 2015 | SESE | | [K150796](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K150796.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com