Data / Medical devices / Drill, Bone, Powered
Drill, Bone, Powered (DZI): 51 FDA-registered makers in 13 countries
51 establishments in 13 countries are registered with the FDA to make Drill, Bone, Powered (product code DZI, Class 2, 21 CFR 872.4120). 24 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 50 510(k) clearances under this code, the latest on July 31, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DZI
- Device class
- 2
- Regulation
- 872.4120
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 17 |
| Switzerland | 13 |
| Germany | 3 |
| Malaysia | 3 |
| France | 2 |
| Italy | 2 |
| Austria | 2 |
| South Korea | 2 |
| China | 2 |
| Sweden | 2 |
| Taiwan | 1 |
| Japan | 1 |
| Denmark | 1 |
Makers of Drill, Bone, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Satelec-Acteon Group | MERIGNAC Gironde, France | Manufacturer | 6 | May 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Mectron S.P.A. | CARASCO Genova, Italy | Complaint file establishment, Manufacturer | 5 | August 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 3 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 3 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bonart Co. Ltd. | Keelung, Taiwan | Contract manufacturer, Manufacturer | 2 | August 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Dmetec Co., Ltd | Bucheon Gyeonggi, South Korea | Manufacturer | 2 | December 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Implant Direct Sybron Manufacturing LLC | Thousand Oaks, CA, United States | Manufacturer | 2 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nakanishi Inc. | Kanuma Tochigi, Japan | Manufacturer | 2 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 2 | July 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Electro Medical Systems, L.L.C. | Southlake, TX, United States | Remanufacturer, Repackager or relabeler | 1 | December 18, 2007 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer | 1 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 1 | November 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 1 | October 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 1 | November 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nouvag AG | GOLDACH Sankt Gallen, Switzerland | Manufacturer | 1 | November 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Silfradent SRL | S.Sofia Forli, Italy | Manufacturer | 1 | April 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | August 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Straumann Villeret SA | VILLERET Bern, Switzerland | Manufacturer | 1 | October 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | August 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Abnox AG | Cham Zug, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baechler Feintech AG | Hoelstein Basel-Landschaft, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Corona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Foothill Ranch, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Pinol A/S | Goerloese Hovedstaden, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare AB | GOTEBORG Vastra Gotaland, Sweden | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare AB, Produktion | KARLSKOGA Orebro, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Procera, LLC | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Services AG | Kloten Zurich, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sphinx Tools Ltd | Derendingen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.