Surgical devices · 21 CFR 872 Subpart E
Powered Bone Drill
FDA device type “Drill, Bone, Powered”.
- Companies listing it
- 5534 makers
- Brands and models
- 209
- 510(k) clearances
- 506 in five years
- FDA name
- Drill, Bone, Powered
510(k) clearances per year, 1976–2026
Companies that list DZI
55 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Straumann Dental Implant System | 212 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Powered Laser Surgical Instrument | 30 | 2026 |
| Nakanishi, Inc. | Japan | Maker | E30LD-S · E30RD-S · E31D-S · E32D-S · +64 | 37 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Trefoil Clinical Screw · TREFOIL Framework | 94 | 2026 |
| Elos Medtech Pinol A/S | Denmark | Maker | Nobel Replace, Nobel Active, Nobel Direct, Branemark System | 14 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Ai-surgery, Surgic smart · Piezo Bone Surgery · Surgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LED · Ultrasurgery · +1 | 12 | 2025 |
| Stryker | United States | Maker | TPS Console · TPS Micro Drill/Elite Attachment Brush · TPS Standard Attachment Brush · TPS Unidirectional Footswitch | 33 | 2024 |
| Implant Direct | United States | Maker | Guided Surgery Kit · Surgical Drills | 24 | 2023 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | PIEZOART · Traus SUS20 | 16 | 2026 |
| Mectron S.P.A. | Italy | Maker | combi touch · MT-Bone · MT11L-10 · MT11R-10 · +6 | 11 | 2025 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Surgical Drive System (model: ES70, ES90, E8) · Surgical Drive System ES70 Kit (model: ES70 K1, ES70 K2) · Surgical Drive System ES90 Kit (model: ES90 K1, ES90 K2, ES90 K3) | 5 | 2026 |
| Satelec - Acteon Group | United States | Maker | Bone cutting Instrument/Accessories · Craniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L -- BS1RD · Drill, Bone , Powered · Drill, Bone, Powered · +11 | 18 | 2024 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Bonart Co., Ltd. | Taiwan | Maker | ARTEOTOMY Oral Surgery System and Accessories (Model No. BIS) · ARTEOTOMY-OM1/OP1 ULT.SURGERY SYS. | 14 | 2017 |
| SYNTHES (USA) Products LLC | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SY · Synthes 90 Degree Screwdriver | 7 | 2020 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SY · Synthes 90 Degree Screwdriver | 5 | 2013 |
| Electro Medical Systems SA | United States | Maker | Piezon Master Surgery | 5 | 2002 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| DMETEC Co., LTD | South Korea | Maker | ULTRASONIC SURGERY · ULTRASONIC SURGERY MACHINE | 5 | 2017 |
| Nouvag AG | Switzerland | Maker | Handpieces ENT · HighSurg 30 · MD 11 · MD 30 | 4 | 2008 |
| ConMed CORP. | United States | Maker | PowerPro Pneumatic | 2 | 2006 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET BONE CUTTING INSTRUMENT AND ACCESSORY | 1 | 2007 |
| Silfradent srl | Italy | Maker | Surgybone | 1 | 2009 |
| Unique Instruments Inc. | United States | Maker | DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M403 · DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M406 · DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M404 · DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M405 · +24 | — | — |
| Micro Precision Swiss, LLC | United States | Maker | Dense Bone Drill · Drill Tapered · Guided Counterbore · Guided Dense Bone Drill Tapered · +3 | — | — |
| Jabil Inc. | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM · Synthes 90 Degree Screwdriver | — | — |
| Frueh Verpackungstechnik AG | Switzerland | Maker | Electric Pen Drive System | — | — |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | Maker | 5100 215 306 BEARING SPACER · 5100-010-028 BEARING PRELOAD RING · 5100-010-239 BEARING SLEEVE · 5110-901-912 NOZZLE | — | — |
| Symmetry Medical Polyvac SAS | France | Maker | PACK PIEZOTOME 2 | — | — |
| Baechler Feintech AG | Switzerland | Maker | Shaft f/Screwdriver 90° | — | — |
| Sphinx Tools Ltd | Switzerland | Maker | SYNTHES | — | — |
| The Anspach Effort Inc | United States | Maker | Electric Pen Drive · Synthes | — | — |
| Abnox AG | Switzerland | Maker | — | — | — |
| Hipp Medical AG | Germany | Maker | — | — | — |
| Dentis Co., Ltd. | South Korea | Foreign exporter | Silfradent SRL | 37 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | NR Piezo | 8 | 2026 |
| Sotera Health LLC | United States | Contract manufacturer | 0300.317S | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | Sonic surgical instrument and accessories/attachments · SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM · SYNTHES 90 DEGREE SCREWDRIVER | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | AI SURGERY | — | — |
| GoldenDent | United States | Repacker / relabeler | Piezo Implant Motor | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | — | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Nakanishi Inc. | — | — |
| EMS Electro Medical Systems SA | Switzerland | Foreign exporter | PIEZON MASTER SURGERY | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | Foot Control · Instrument changer · Instrument Set BONE · Instrument Set ENDO · +3 | — | — |
| Piezosurgery, Inc DBA Mectron North America | United States | Lister | MT-Bone · Piezosurgery // · Piezosurgery 3 · Piezosurgery Flex · +4 | — | — |
| DePuy Synthes, Inc. | United States | Manufacturer | Synthes 90 Degree Screwdriver | — | — |
| Enova Illumination Inc. | United States | Lister | Piezo Surgery | — | — |
| Rose GmbH fuer Medizintechnik | Germany | Contract sterilizer | — | — | — |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Türkiye | Foreign exporter | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | — | — |
| Nouvatec LLC | United States | Repacker / relabeler | Nouvag AG | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| SOMI medical GmbH | Germany | Contract sterilizer | — | — | — |
| Veenak International Limited | United Kingdom | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 31 Jul 2026 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH |
| 18 Jun 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH |
| 23 Dec 2025 | K254163 | VarioSurg 4 | Nakanishi, Inc. |
| 19 Aug 2024 | K242432 | MT-Bone | Mectron S.P.A. |
| 18 Jul 2024 | K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong JINME Medical Technology Co., Ltd. |
| 16 Aug 2023 | K231087 | Guided Surgery Kit | Implant Direct |
| 13 Jul 2020 | K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. |
| 30 Jun 2020 | K200265 | Surgical Drills | Implant Direct |
| 9 Jun 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. |
| 3 May 2018 | K172137 | PIEZOTOME CUBE | Satelec - Acteon Group |
| 13 Apr 2018 | K171326 | Piezosurgery White | Mectron S.P.A. |
| 12 Jan 2018 | K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. |
| 15 Aug 2016 | K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. |
| 4 Sep 2015 | K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. |
| 1 Sep 2015 | K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. |
| 2 Jun 2015 | K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. |
| 16 Oct 2014 | K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH |
| 11 Dec 2012 | K121620 | ULTRASONIC SURGERY | DMETEC Co., LTD |
| 6 Dec 2012 | K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. |
| 14 Jun 2012 | K113152 | ULTRASONIC SURGERY MACHINE | DMETEC Co., LTD |
| 3 Feb 2012 | K112188 | PIEZOTOME SOLO | Satelec - Acteon, Inc. |
| 16 Dec 2011 | K110881 | ULTRASONIC SURGICAL UNIT | Dong IL Technology , Ltd. |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 29 Dec 2009 | K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. |
| 11 Dec 2009 | K091331 | PIEZOTOME 2 | Satelec |
| 22 Jul 2009 | K091252 | IMPLANT CENTER 2 | Satelec |
| 30 Apr 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) |
| 1 Apr 2009 | K083569 | SURGYBONE | Silfradent srl |
| 21 Oct 2008 | K082532 | STRAUMANN GUIDED INSTRUMENTS | Institut Straumann AG |
| 25 Aug 2008 | K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Bonart Co., Ltd. |
| 28 Jul 2008 | K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | Italia Medica S.R.L. |
| 10 Jul 2008 | K073678 | VARIOSURG | Nakanishi, Inc. |
| 18 Dec 2007 | K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A |
| 19 Nov 2007 | K072030 | IMPLANT CENTER | Satelec - Acteon Group |
| 1 May 2006 | K060274 | PIEZOTOME | Satelec |
| 10 Apr 2006 | K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | ConMed CORP. |
| 8 Jun 2005 | K043408 | PIEZOSURGERY DEVICE | Piezosurgery S.R.L. |
| 3 Nov 2004 | K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | Nouvag AG |
| 10 Nov 2003 | K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | ConMed CORP. |
| 8 Aug 2003 | K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | Stryker |
| 25 Oct 1999 | K991696 | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM | Stryker |
| 10 Jun 1999 | K990846 | AMORPHOUS DIAMOND COATED DRILL | Nobel Biocare Uas, Inc. |
| 20 Aug 1996 | K954690 | STRYKER ORAL MAX SYSTEM | Stryker |
| 23 Nov 1987 | K874535 | MICROTEK MINI-MAX DRILL SYSTEM | Microtek Medical, Inc. |
| 8 Jun 1987 | K871648 | TMJ CANNULA SET | Aspen Laboratories, Inc. |
| 28 Jan 1981 | K803291 | ARTUS DRILL #2000 | Jedmed Instrument Co. |
| 28 Jan 1981 | K803290 | ARTUS DRILL #3000 | Jedmed Instrument Co. |
| 28 Jan 1981 | K803289 | ARTUS DRILL #4000 | Jedmed Instrument Co. |
| 28 Jan 1981 | K803288 | ARTUS DRILL #6000 | Jedmed Instrument Co. |
| 17 Oct 1979 | K791326 | MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL | Sherwood Medical Co. |
Official records: FDA product classification for DZI · 21 CFR 872.4120.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026