FDA 510(k) Applications for Medical Device Product Code "DZI"
(Drill, Bone, Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K192033 | Bennett Jacoby, DDS, MS, Inc. | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | 06/09/2020 |
| K080761 | BONART CO. LTD. | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | 08/25/2008 |
| K152125 | BONART CO., LTD. | Oral Surgery System and Accessories | 08/15/2016 |
| K121620 | DMETEC CO., LTD. | ULTRASONIC SURGERY | 12/11/2012 |
| K113152 | DMETEC CO., LTD. | ULTRASONIC SURGERY MACHINE | 06/14/2012 |
| K150076 | DONG IL TECHNOLOGY LTD. | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | 06/02/2015 |
| K110881 | DONG IL TECHNOLOGY LTD. | ULTRASONIC SURGICAL UNIT | 12/16/2011 |
| K072146 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | EMS PIEZON MASTER SURGERY | 12/18/2007 |
| K111290 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD | PIEZO BONE SURGERY | 11/18/2011 |
| K231087 | Implant Direct Sybron Manufacturing, LLC | Guided Surgery Kit | 08/16/2023 |
| K200265 | Implant Direct Sybron Manufacturing, LLC | Surgical Drills | 06/30/2020 |
| K080220 | ITALIA MEDICA S.R.L. | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | 07/28/2008 |
| K060270 | LINVATEC CORP. | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | 04/10/2006 |
| K032607 | LINVATEC CORP. | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | 11/10/2003 |
| K171326 | Mectron S.p.a | Piezosurgery White | 04/13/2018 |
| K122322 | MECTRON S.P.A. | PIEZOSURGERY TOUCH | 12/06/2012 |
| K171958 | Mectron SPA | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | 01/12/2018 |
| K151248 | MECTRON SPA | PIEZOSURGERY WHITE | 09/04/2015 |
| K073678 | NAKANISHI, INC. | VARIOSURG | 07/10/2008 |
| K990846 | NOBEL BIOCARE UAS INC | AMORPHOUS DIAMOND COATED DRILL | 06/10/1999 |
| K042434 | NOUVAG AG | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | 11/03/2004 |
| K091227 | PIEZOSURGERY S.R.L. | PIEZOSURGERY 3; OSSTEM PIEZO | 12/29/2009 |
| K043408 | PIEZOSURGERY SRL | PIEZOSURGERY DEVICE | 06/08/2005 |
| K151171 | SAESHIN PRECISION CO., LTD. | TRAUS SUS10 | 09/01/2015 |
| K192561 | Saeshin Precision Co., Ltd. | TRAUS SUS20 | 07/13/2020 |
| K091252 | SATELEC | IMPLANT CENTER 2 | 07/22/2009 |
| K060274 | SATELEC | PIEZOTOME | 05/01/2006 |
| K091331 | SATELEC | PIEZOTOME 2 | 12/11/2009 |
| K172137 | Satelec - Acteon Group | PIEZOTOME CUBE | 05/03/2018 |
| K112188 | SATELEC - ACTEON, INC. | PIEZOTOME SOLO | 02/03/2012 |
| K072030 | SATELEC-ACTEON GROUP | IMPLANT CENTER | 11/19/2007 |
| K083569 | SILFRADENT S.R.L. | SURGYBONE | 04/01/2009 |
| K082532 | STRAUMANN USA | STRAUMANN GUIDED INSTRUMENTS | 10/21/2008 |
| K954690 | STRYKER CORP. | STRYKER ORAL MAX SYSTEM | 08/20/1996 |
| K991696 | STRYKER INSTRUMENTS | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM | 10/25/1999 |
| K032117 | STRYKER INSTRUMENTS | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | 08/08/2003 |
| K082649 | SYNTHES (USA) | SYNTHES 90 DEGREE SCREWDRIVER | 04/30/2009 |
| K133488 | W & H DENTALWERK BUERMOOS GMBH | PIEZOMED | 10/16/2014 |
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