Drill, Bone, Powered
FDA product code DZI · Class II (moderate risk) · 21 CFR 872.4120 · Dental
50510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Mectron S.P.A. 5
- Jedmed Instrument Co. 4
- Satelec 3
- Dong IL Technology , Ltd. 2
- Dmetec.Co., Ltd. 2
- Stryker Instruments 2
- Linvatec Corp. 2
- Piezosurgery S.R.L. 2
- Satelec - Acteon Group 2
- Saeshin Precision Co., Ltd. 2
- Nakanishi, Inc. 2
- Implant Direct Sybron Manufacturing, LLC 2
- Bonart Co., Ltd. 2
- W&H Dentalwerk Buermoos GmbH 2
- E.M.S Electro Medical Systems S.A 1
- Aspen Laboratories, Inc. 1
- Silfradent S.R.L. 1
- Sherwood Medical Co. 1
- Nouvag AG 1
- W&H Dentalwerk Bürmoos GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K242432 | MT-BoneDZI · Traditional | Mectron S.P.A. | 08/19/2024SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
| K171326 | Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 04/13/2018SE |
| K171958 | Piezosurgery Touch, Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 01/12/2018SE |
| K152125 | Oral Surgery System and AccessoriesDZI · Traditional | Bonart Co., Ltd. | 08/15/2016SE |
| K151248 | Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 09/04/2015SE |
| K151171 | Traus SUS10DZI · Traditional | Saeshin Precision Co., Ltd. | 09/01/2015SE |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDZI · Traditional | Dong IL Technology , Ltd. | 06/02/2015SE |
| K133488 | PiezomedDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 10/16/2014SE |
| K121620 | Ultrasonic SurgeryDZI · Traditional | Dmetec.Co., Ltd. | 12/11/2012SE |
| K122322 | Piezosurgery TouchDZI · Traditional | Mectron S.P.A. | 12/06/2012SE |
| K113152 | Ultrasonic Surgery MachineDZI · Traditional | Dmetec.Co., Ltd. | 06/14/2012SE |
| K112188 | Piezotome SoloDZI · Traditional | Satelec - Acteon, Inc. | 02/03/2012SE |
| K110881 | Ultrasonic Surgical UnitDZI · Traditional | Dong IL Technology , Ltd. | 12/16/2011SE |
| K111290 | Piezo Bone SurgeryDZI · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/18/2011SE |
| K091227 | Piezosurgery 3; Osstem PiezoDZI · Traditional | Piezosurgery S.R.L. | 12/29/2009SE |
| K091331 | Piezotome 2DZI · Traditional | Satelec | 12/11/2009SE |
| K091252 | Implant Center 2DZI · Traditional | Satelec | 07/22/2009SE |
| K082649 | Synthes 90 Degree ScrewdriverDZI · Traditional | Synthes (Usa) | 04/30/2009SE |
| K083569 | SurgyboneDZI · Abbreviated | Silfradent S.R.L. | 04/01/2009SE |
| K082532 | Straumann Guided InstrumentsDZI · Traditional | Straumann USA | 10/21/2008SE |
| K080761 | Bonart's Arteotomy Omi and Opi Ultrasonic Surgery System & AccessoriesDZI · Traditional | Bonart Co., Ltd. | 08/25/2008SE |
| K080220 | Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment DeviceDZI · Abbreviated | Italia Medica S.R.L. | 07/28/2008SE |
| K073678 | VariosurgDZI · Traditional | Nakanishi, Inc. | 07/10/2008SE |
| K072146 | EMS Piezon Master SurgeryDZI · Traditional | E.M.S Electro Medical Systems S.A | 12/18/2007SE |
| K072030 | Implant CenterDZI · Traditional | Satelec - Acteon Group | 11/19/2007SE |
| K060274 | PiezotomeDZI · Traditional | Satelec | 05/01/2006SE |
| K060270 | Micropower Hand Piece: Oral Max High Speed DrillDZI · Special | Linvatec Corp. | 04/10/2006SE |
| K043408 | Piezosurgery DeviceDZI · Traditional | Piezosurgery S.R.L. | 06/08/2005SE |
| K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55DZI · Traditional | Nouvag AG | 11/03/2004SE |
| K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185DZI · Traditional | Linvatec Corp. | 11/10/2003SE |
| K032117 | Stryker Total Performance (TPS) SystemDZI · Special | Stryker Instruments | 08/08/2003SE |
| K991696 | Stryker Hermes-Ready Total Performance SystemDZI · Traditional | Stryker Instruments | 10/25/1999SE |
| K990846 | Amorphous Diamond Coated DrillDZI · Traditional | Nobel Biocare Uas, Inc. | 06/10/1999SE |
| K954690 | Stryker Oral Max SystemDZI · Traditional | Stryker Corp. | 08/20/1996SE |
| K874535 | Microtek Mini-Max Drill SystemDZI · Traditional | Microtek Medical, Inc. | 11/23/1987SE |
| K871648 | TMJ Cannula SetDZI · Traditional | Aspen Laboratories, Inc. | 06/08/1987SE |
| K803291 | Artus Drill #2000DZI · Traditional | Jedmed Instrument Co. | 01/28/1981SE |
| K803290 | Artus Drill #3000DZI · Traditional | Jedmed Instrument Co. | 01/28/1981SE |
| K803289 | Artus Drill #4000DZI · Traditional | Jedmed Instrument Co. | 01/28/1981SE |
| K803288 | Artus Drill #6000DZI · Traditional | Jedmed Instrument Co. | 01/28/1981SE |
| K791326 | Monoject Endosseous Dental Implant ToolDZI · Traditional | Sherwood Medical Co. | 10/17/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1323-2020 Class II | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1315-2020 Class II | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1314-2020 Class II | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1313-2020 Class II | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1312-2020 Class II | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1311-2020 Class II | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1310-2020 Class II | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1309-2020 Class II | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1308-2020 Class II | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1307-2020 Class II | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1306-2020 Class II | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1305-2020 Class II | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1304-2020 Class II | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-1303-2020 Class II | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | Nobel Biocare Usa Llc | 03/14/2019Terminated |
| Z-2375-2016 Class II | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use…Incorrect drill protocol in the Instructions for Use (IFU) | Nobel Biocare Usa Llc | 07/20/2016Terminated |
| Z-0263-2010 | Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF…The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking… | Stryker Instruments Div. of Stryker… | 10/05/2009Terminated |