Product code DZI
- Device name
- Drill, Bone, Powered
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4120
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | 2026-06-18 |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 2025-12-23 |
| K242432 | MT-Bone | Mectron S.P.A. | 2024-08-19 |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-07-18 |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | 2023-08-16 |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | 2020-07-13 |
| K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | 2020-06-30 |
| 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. | 2020-06-09 |
| K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | 2018-05-03 |
| K171326 | Piezosurgery White | Mectron S.P.A. | 2018-04-13 |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | 2018-01-12 |
| K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | 2016-08-15 |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | 2015-09-04 |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2015-09-01 |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | 2015-06-02 |
| K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH | 2014-10-16 |
| K121620 | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | 2012-12-11 |
| K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. | 2012-12-06 |
| K113152 | ULTRASONIC SURGERY MACHINE | Dmetec.Co., Ltd. | 2012-06-14 |
| K112188 | PIEZOTOME SOLO | Satelec - Acteon, Inc. | 2012-02-03 |
| K110881 | ULTRASONIC SURGICAL UNIT | Dong IL Technology , Ltd. | 2011-12-16 |
| K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | 2011-11-18 |
| K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | 2009-12-29 |
| K091331 | PIEZOTOME 2 | Satelec | 2009-12-11 |
| K091252 | IMPLANT CENTER 2 | Satelec | 2009-07-22 |
| K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | 2009-04-30 |
| K083569 | SURGYBONE | Silfradent S.R.L. | 2009-04-01 |
| K082532 | STRAUMANN GUIDED INSTRUMENTS | Straumann USA | 2008-10-21 |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Bonart Co., Ltd. | 2008-08-25 |
| K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | Italia Medica S.R.L. | 2008-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982065070 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065414 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065407 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065391 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065339 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065322 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065292 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065261 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065230 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065216 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065155 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065148 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065131 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065094 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065087 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064721 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065063 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065049 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065032 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065001 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064943 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064936 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064929 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064912 | NA | Synthes GmbH | 2016-06-30 |
| 10886982064905 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064882 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064844 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064820 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064745 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064738 | NA | Synthes GmbH | 2016-06-30 |