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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.

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Product code
DZJ
Device class
2
Regulation
872.4120
Medical specialty
Dental

Makers by country

CountryMakers
United States22
Switzerland7
Germany4
Malaysia4
Austria2
Belgium1
Colombia1
Ukraine1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer4April 26, 2021010api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer2December 11, 2024000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer2March 11, 2019000api.fda.gov
Materialise N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer2October 9, 2026000api.fda.gov
MedCADPlano, TX, United StatesManufacturer2March 7, 2023000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer2April 1, 2004000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer2March 7, 2023000api.fda.gov
Dental Wings GMBHChemnitz Saxony, GermanyManufacturer, Specification developer1June 21, 2021000api.fda.gov
ImmersiveTouch, Inc.Chicago, IL, United StatesManufacturer1June 9, 2020000api.fda.gov
Insight Surgery HoustonHouston, TX, United StatesManufacturer1September 30, 2022000api.fda.gov
Materialise Colombia S.A.SMedellin Antioquia, ColombiaManufacturer1February 21, 2025000api.fda.gov
Materialise Sdn BhdPetaling Jaya Selangor, MalaysiaManufacturer1February 21, 2025000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer1February 21, 2025000api.fda.gov
Materialise Ukraine, Rep. officeKyiv Kyyiv, Misto, UkraineManufacturer1February 21, 2025000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1June 23, 2015000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesManufacturer1June 21, 2021000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1June 23, 2015000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1June 23, 2015000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Insight Surgery NebraskaOmaha, NE, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Sphinx Tools LtdDerendingen Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer0000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaExporter to the US, Manufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaExporter to the US, Manufacturer0000api.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.