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.
Cleared Devices (48)
| 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 |
| K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | Nov 18, 2011 | SESE |
| K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | Dec 29, 2009 | SESE |
| K091331 | PIEZOTOME 2 | Satelec | Dec 11, 2009 | SESE |
| K091252 | IMPLANT CENTER 2 | Satelec | Jul 22, 2009 | SESE |
| K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | Apr 30, 2009 | SESE |
| K083569 | SURGYBONE | Silfradent S.R.L. | Apr 1, 2009 | SESE |
| K082532 | STRAUMANN GUIDED INSTRUMENTS | Straumann USA | Oct 21, 2008 | SESE |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Bonart Co., Ltd. | Aug 25, 2008 | SESE |
| K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | Italia Medica S.R.L. | Jul 28, 2008 | SESE |
| K073678 | VARIOSURG | Nakanishi, Inc. | Jul 10, 2008 | SESE |
| K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | Dec 18, 2007 | SESE |
| K072030 | IMPLANT CENTER | Satelec - Acteon Group | Nov 19, 2007 | SESE |
| K060274 | PIEZOTOME | Satelec | May 1, 2006 | SESE |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Linvatec Corp. | Apr 10, 2006 | SESE |
| K043408 | PIEZOSURGERY DEVICE | Piezosurgery S.R.L. | Jun 8, 2005 | SESE |
| K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | NOUVAG AG | Nov 3, 2004 | SESE |
| K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | Linvatec Corp. | Nov 10, 2003 | SESE |
| K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | Stryker Instruments | Aug 8, 2003 | SESE |
| K991696 | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM | Stryker Instruments | Oct 25, 1999 | SESE |
| K990846 | AMORPHOUS DIAMOND COATED DRILL | Nobel Biocare Uas, Inc. | Jun 10, 1999 | SESE |
| K954690 | STRYKER ORAL MAX SYSTEM | Stryker Corp. | Aug 20, 1996 | SESE |
| K874535 | MICROTEK MINI-MAX DRILL SYSTEM | Microtek Medical, Inc. | Nov 23, 1987 | SESE |
| K871648 | TMJ CANNULA SET | Aspen Laboratories, Inc. | Jun 8, 1987 | SESE |
| K803291 | ARTUS DRILL #2000 | Jedmed Instrument Co. | Jan 28, 1981 | SESE |
| K803290 | ARTUS DRILL #3000 | Jedmed Instrument Co. | Jan 28, 1981 | SESE |
| K803289 | ARTUS DRILL #4000 | Jedmed Instrument Co. | Jan 28, 1981 | SESE |
| K803288 | ARTUS DRILL #6000 | Jedmed Instrument Co. | Jan 28, 1981 | SESE |
| K791326 | MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL | Sherwood Medical Co. | Oct 17, 1979 | 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
