Drill, Bone, Powered
Regulation 872.4120
3510(k)s in 12 months (50 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in DZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare Usa Llc | 0 | 15 |
| Implant Innovations, Inc. | 0 | 5 |
| Mectron S.P.A. | 5 | 0 |
| Jedmed Instrument Co. | 4 | 0 |
| Satelec | 3 | 0 |
| Bonart Co., Ltd. | 2 | 0 |
| Dmetec.Co., Ltd. | 2 | 0 |
| Dong IL Technology , Ltd. | 2 | 0 |
| Implant Direct Sybron Manufacturing, LLC | 2 | 0 |
| Linvatec Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K253655 | Angled Screwdriver MED (M-SD090) W&H Dentalwerk Bürmoos GmbH, AT | DZI |
| Jun 18, 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module W&H Dentalwerk Buermoos GmbH, AT | DZI |
| Dec 23, 2025 | K254163 | VarioSurg 4 Nakanishi, Inc., JP | DZI |
| Aug 19, 2024 | K242432 | MT-Bone Mectron S.P.A., IT | DZI |
| Jul 18, 2024 | K240340 | Surgical Drive System (Model: ES70, ES90, E8) Guangdong Jinme Medical Technology Co., Ltd., CN | DZI |
| Aug 16, 2023 | K231087 | Guided Surgery Kit Implant Direct Sybron Manufacturing, LLC | DZI |
| Jul 13, 2020 | K192561 | TRAUS SUS20 Saeshin Precision Co., Ltd., KR | DZI |
| Jun 30, 2020 | K200265 | Surgical Drills Implant Direct Sybron Manufacturing, LLC | DZI |
| Jun 9, 2020 | 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. | DZI |
| May 3, 2018 | K172137 | PIEZOTOME CUBE Satelec - Acteon Group, FR | DZI |
| Apr 13, 2018 | K171326 | Piezosurgery White Mectron S.P.A., IT | DZI |
| Jan 12, 2018 | K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE Mectron S.P.A., IT | DZI |
| Aug 15, 2016 | K152125 | Oral Surgery System and Accessories Bonart Co., Ltd., TW | DZI |
| Sep 4, 2015 | K151248 | PIEZOSURGERY WHITE Mectron S.P.A., IT | DZI |
| Sep 1, 2015 | K151171 | TRAUS SUS10 Saeshin Precision Co., Ltd., KR | DZI |
| Jun 2, 2015 | K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L Dong IL Technology , Ltd., KR | DZI |
| Oct 16, 2014 | K133488 | PIEZOMED W&H Dentalwerk Buermoos GmbH, AT | DZI |
| Dec 11, 2012 | K121620 | ULTRASONIC SURGERY Dmetec.Co., Ltd. | DZI |
| Dec 6, 2012 | K122322 | PIEZOSURGERY TOUCH Mectron S.P.A., IT | DZI |
| Jun 14, 2012 | K113152 | ULTRASONIC SURGERY MACHINE Dmetec.Co., Ltd. | DZI |
| Feb 3, 2012 | K112188 | PIEZOTOME SOLO Satelec - Acteon, Inc. | DZI |
| Dec 16, 2011 | K110881 | ULTRASONIC SURGICAL UNIT Dong IL Technology , Ltd. | DZI |
| Nov 18, 2011 | K111290 | PIEZO BONE SURGERY Guilin Woodpecker Medical Instrument Co., Ltd. | DZI |
| Dec 29, 2009 | K091227 | PIEZOSURGERY 3; OSSTEM PIEZO Piezosurgery S.R.L., IT | DZI |
| Dec 11, 2009 | K091331 | PIEZOTOME 2 Satelec | DZI |
| Jul 22, 2009 | K091252 | IMPLANT CENTER 2 Satelec | DZI |
| Apr 30, 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER Synthes (Usa) | DZI |
| Apr 1, 2009 | K083569 | SURGYBONE Silfradent S.R.L. | DZI |
| Oct 21, 2008 | K082532 | STRAUMANN GUIDED INSTRUMENTS Straumann USA | DZI |
| Aug 25, 2008 | K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES Bonart Co., Ltd. | DZI |
| Jul 28, 2008 | K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE Italia Medica S.R.L. | DZI |
| Jul 10, 2008 | K073678 | VARIOSURG Nakanishi, Inc. | DZI |
| Dec 18, 2007 | K072146 | EMS PIEZON MASTER SURGERY E.M.S Electro Medical Systems S.A | DZI |
| Nov 19, 2007 | K072030 | IMPLANT CENTER Satelec - Acteon Group | DZI |
| May 1, 2006 | K060274 | PIEZOTOME Satelec | DZI |
| Apr 10, 2006 | K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL Linvatec Corp. | DZI |
| Jun 8, 2005 | K043408 | PIEZOSURGERY DEVICE Piezosurgery S.R.L., IT | DZI |
| Nov 3, 2004 | K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 NOUVAG AG, CH | DZI |
| Nov 10, 2003 | K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 Linvatec Corp. | DZI |
| Aug 8, 2003 | K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM Stryker Instruments | DZI |
| Oct 25, 1999 | K991696 | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM Stryker Instruments | DZI |
| Jun 10, 1999 | K990846 | AMORPHOUS DIAMOND COATED DRILL Nobel Biocare Uas, Inc. | DZI |
| Aug 20, 1996 | K954690 | STRYKER ORAL MAX SYSTEM Stryker Corp. | DZI |
| Nov 23, 1987 | K874535 | MICROTEK MINI-MAX DRILL SYSTEM Microtek Medical, Inc. | DZI |
| Jun 8, 1987 | K871648 | TMJ CANNULA SET Aspen Laboratories, Inc. | DZI |
| Jan 28, 1981 | K803291 | ARTUS DRILL #2000 Jedmed Instrument Co. | DZI |
| Jan 28, 1981 | K803290 | ARTUS DRILL #3000 Jedmed Instrument Co. | DZI |
| Jan 28, 1981 | K803289 | ARTUS DRILL #4000 Jedmed Instrument Co. | DZI |
| Jan 28, 1981 | K803288 | ARTUS DRILL #6000 Jedmed Instrument Co. | DZI |
| Oct 17, 1979 | K791326 | MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL Sherwood Medical Co. | DZI |
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