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) → DZI — Drill, Bone, Powered # DZI · Drill, Bone, Powered _Dental · 21 CFR 872.4120 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI ## Overview - **Product Code:** DZI - **Device Name:** Drill, Bone, Powered - **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 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254163](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K254163.md) | VarioSurg 4 | Nakanishi, Inc. | Dec 23, 2025 | SESE | | [K242432](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K242432.md) | MT-Bone | Mectron S.P.A. | Aug 19, 2024 | SESE | | [K240340](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K240340.md) | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | Jul 18, 2024 | SESE | | [K231087](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K231087.md) | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | Aug 16, 2023 | SESE | | [K192561](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K192561.md) | TRAUS SUS20 | Saeshin Precision Co., Ltd. | Jul 13, 2020 | SESE | | [K200265](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K200265.md) | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | Jun 30, 2020 | SESE | | [K192033](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K192033.md) | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | Bennett Jacoby, Dds, Ms, Inc. | Jun 9, 2020 | SESE | | [K172137](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K172137.md) | PIEZOTOME CUBE | Satelec - Acteon Group | May 3, 2018 | SESE | | [K171326](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K171326.md) | Piezosurgery White | Mectron S.P.A. | Apr 13, 2018 | SESE | | [K171958](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K171958.md) | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | Jan 12, 2018 | SESE | | [K152125](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K152125.md) | Oral Surgery System and Accessories | Bonart Co., Ltd. | Aug 15, 2016 | SESE | | [K151248](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K151248.md) | PIEZOSURGERY WHITE | Mectron S.P.A. | Sep 4, 2015 | SESE | | [K151171](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K151171.md) | TRAUS SUS10 | Saeshin Precision Co., Ltd. | Sep 1, 2015 | SESE | | [K150076](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K150076.md) | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | Jun 2, 2015 | SESE | | [K133488](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K133488.md) | PIEZOMED | W&H Dentalwerk Buermoos GmbH | Oct 16, 2014 | SESE | | [K121620](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K121620.md) | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | Dec 11, 2012 | SESE | | [K122322](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K122322.md) | PIEZOSURGERY TOUCH | Mectron S.P.A. | Dec 6, 2012 | SESE | | [K113152](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K113152.md) | ULTRASONIC SURGERY MACHINE | Dmetec.Co., Ltd. | Jun 14, 2012 | SESE | | [K112188](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K112188.md) | PIEZOTOME SOLO | Satelec - Acteon, Inc. | Feb 3, 2012 | SESE | | [K110881](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K110881.md) | ULTRASONIC SURGICAL UNIT | Dong IL Technology , Ltd. | Dec 16, 2011 | SESE | ## Top Applicants - Mectron S.P.A. — 5 clearances - Jedmed Instrument Co. — 4 clearances - Satelec — 3 clearances - Stryker Instruments — 2 clearances - Satelec - Acteon Group — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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