DZI · Drill, Bone, Powered
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | DZI |
|---|---|
| Device Name | Drill, Bone, Powered |
| 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 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254163 | VarioSurg 4 | Nakanishi, Inc. | Dec 23, 2025 | SESE |
| K242432 | MT-Bone | Mectron S.P.A. | Aug 19, 2024 | SESE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | Jul 18, 2024 | SESE |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | Aug 16, 2023 | SESE |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | Jul 13, 2020 | SESE |
| K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | Jun 30, 2020 | SESE |
| K192033 | 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 | PIEZOTOME CUBE | Satelec - Acteon Group | May 3, 2018 | SESE |
| K171326 | Piezosurgery White | Mectron S.P.A. | Apr 13, 2018 | SESE |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | Jan 12, 2018 | SESE |
| K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | Aug 15, 2016 | SESE |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | Sep 4, 2015 | SESE |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | Sep 1, 2015 | SESE |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | Jun 2, 2015 | SESE |
| K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH | Oct 16, 2014 | SESE |
| K121620 | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | Dec 11, 2012 | SESE |
| K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. | Dec 6, 2012 | SESE |
| K113152 | ULTRASONIC SURGERY MACHINE | Dmetec.Co., Ltd. | Jun 14, 2012 | SESE |
| K112188 | PIEZOTOME SOLO | Satelec - Acteon, Inc. | Feb 3, 2012 | SESE |
| K110881 | 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
- Bonart Co., Ltd. — 2 clearances
- Dmetec.Co., Ltd. — 2 clearances
