Data / Medical devices / Driver, Wire, And Bone Drill, Manual
Driver, Wire, And Bone Drill, Manual (DZJ): 42 FDA-registered makers in 8 countries
42 establishments in 8 countries are registered with the FDA to make Driver, Wire, And Bone Drill, Manual (product code DZJ, Class 2, 21 CFR 872.4120). 18 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on October 9, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- DZJ
- Device class
- 2
- Regulation
- 872.4120
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 22 |
| Switzerland | 7 |
| Germany | 4 |
| Malaysia | 4 |
| Austria | 2 |
| Belgium | 1 |
| Colombia | 1 |
| Ukraine | 1 |
Makers of Driver, Wire, And Bone Drill, Manual
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Manufacturer | 4 | April 26, 2021 | 0 | 1 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 2 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 2 | March 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 2 | October 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| MedCAD | Plano, TX, United States | Manufacturer | 2 | March 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 2 | April 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| VanDuzen, Inc. dba MedCAD | Dallas, TX, United States | Manufacturer | 2 | March 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dental Wings GMBH | Chemnitz Saxony, Germany | Manufacturer, Specification developer | 1 | June 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| ImmersiveTouch, Inc. | Chicago, IL, United States | Manufacturer | 1 | June 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Insight Surgery Houston | Houston, TX, United States | Manufacturer | 1 | September 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | Manufacturer | 1 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Materialise Sdn Bhd | Petaling Jaya Selangor, Malaysia | Manufacturer | 1 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 1 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Materialise Ukraine, Rep. office | Kyiv Kyyiv, Misto, Ukraine | Manufacturer | 1 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | June 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Manufacturer | 1 | June 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 1 | June 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | June 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baechler Feintech AG | Hoelstein Basel-Landschaft, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insight Surgery Nebraska | Omaha, NE, United States | 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 Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Manufacturing, LLC | Jacksonville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomed | Addison, TX, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, 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 Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 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.