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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

CountryMakers
United States17
Switzerland13
Germany3
Malaysia3
France2
Italy2
Austria2
South Korea2
China2
Sweden2
Taiwan1
Japan1
Denmark1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Satelec-Acteon GroupMERIGNAC Gironde, FranceManufacturer6May 3, 2018000api.fda.gov
Mectron S.P.A.CARASCO Genova, ItalyComplaint file establishment, Manufacturer5August 19, 2024000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaExporter to the US, Manufacturer3July 31, 2026000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaExporter to the US, Manufacturer3July 31, 2026000api.fda.gov
Bonart Co. Ltd.Keelung, TaiwanContract manufacturer, Manufacturer2August 15, 2016000api.fda.gov
Dmetec Co., LtdBucheon Gyeonggi, South KoreaManufacturer2December 11, 2012000api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer2August 16, 2023000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanManufacturer2December 23, 2025000api.fda.gov
Saeshin Precision Co., Ltd.Daegu, South KoreaManufacturer2July 13, 2020000api.fda.gov
Electro Medical Systems, L.L.C.Southlake, TX, United StatesRemanufacturer, Repackager or relabeler1December 18, 2007000api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer1July 18, 2024000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer1November 18, 2011000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandSpecification developer1October 21, 2008000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer1November 10, 2003000api.fda.gov
Nouvag AGGOLDACH Sankt Gallen, SwitzerlandManufacturer1November 3, 2004000api.fda.gov
Silfradent SRLS.Sofia Forli, ItalyManufacturer1April 1, 2009000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1August 8, 2003000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1April 30, 2009000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer1April 30, 2009000api.fda.gov
Straumann Villeret SAVILLERET Bern, SwitzerlandManufacturer1October 21, 2008000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1August 8, 2003000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1April 30, 2009000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1April 30, 2009000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1April 30, 2009000api.fda.gov
Abnox AGCham Zug, SwitzerlandContract manufacturer0000api.fda.gov
Asi Medical, Inc.Englewood, CO, United StatesManufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Biolase MG LLCCorona, CA, United StatesManufacturer0000api.fda.gov
Biolase MG LLCFoothill Ranch, CA, United StatesSpecification developer0000api.fda.gov
Elos Medtech Pinol A/SGoerloese Hovedstaden, DenmarkContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract 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 Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer0000api.fda.gov
Nobel Biocare AB, ProduktionKARLSKOGA Orebro, SwedenContract manufacturer0000api.fda.gov
Nobel Biocare Procera, LLCMahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer0000api.fda.gov
Orchid UniqueBridgeport, 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 Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.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.