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Data / Medical devices / Implant, Endosseous, Root-Form / United States

FDA-registered makers of Implant, Endosseous, Root-Form in the United States: 83 establishments

83 establishments in the United States are registered with the FDA to make Implant, Endosseous, Root-Form (product code DZE). 54 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Implant, Endosseous, Root-Form
Product code
DZE
Country
United States

Makers of Implant, Endosseous, Root-Form in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
ZimVie US Corp LLCPalm Beach Gardens, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer63October 23, 20240300api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export34July 9, 2024000api.fda.gov
Straumann Manufacturing, Inc.Andover, MA, United StatesManufacturer34September 14, 2023000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer25September 28, 2017000api.fda.gov
Biohorizons Implant Systems Inc.Birmingham, AL, United StatesComplaint file establishment, Manufacturer, Manufacturer for export24June 5, 2024080api.fda.gov
Bicon, LLCBoston, MA, United StatesSpecification developer11October 1, 2010000api.fda.gov
Hiossen Inc.Fairless Hills, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler10September 13, 2024010api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer9February 2, 20230180api.fda.gov
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer8December 12, 2013000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer8June 30, 2022000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer7April 15, 2021030api.fda.gov
Zest Anchors, LLCEscondido, CA, United StatesManufacturer7April 15, 2021000api.fda.gov
Osseofuse International Inc.Las Vegas, NV, United StatesSpecification developer5October 10, 2025000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer5May 23, 2016000api.fda.gov
Biodent IncEncino, CA, United StatesSpecification developer4July 21, 2010000api.fda.gov
Oco BiomedicalAlbuquerque, NM, United StatesManufacturer, Repackager or relabeler4September 14, 2009000api.fda.gov
Paragon Implant Company, LLCLas Vegas, NV, United StatesManufacturer4September 17, 2026000api.fda.gov
Paragon Implant MFG., LLCCalabasas, CA, United StatesComplaint file establishment, Manufacturer4September 17, 2026000api.fda.gov
PREAT CorporationSanta Maria, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer4December 14, 2016000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer, Specification developer4September 24, 2012000api.fda.gov
American Dental Implant CorporationNew Castle, PA, United StatesSpecification developer3September 21, 2004000api.fda.gov
Basic Dental Implant Systems, Inc.Rio Rancho, NM, United StatesManufacturer3December 4, 2008000api.fda.gov
Biotech DentalEnglewood, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer3July 15, 2022000api.fda.gov
DiamodentDana Point, CA, United StatesManufacturer, Specification developer3January 30, 2004000api.fda.gov
Dentium USACypress, CA, United StatesManufacturer3February 23, 2022010api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer, Manufacturer3August 18, 2025000api.fda.gov
Titan Implants, Inc.Bergenfield, NJ, United StatesManufacturer3January 14, 2005000api.fda.gov
Zentek Medical LLCManalapan, NJ, United StatesSpecification developer3December 20, 2022000api.fda.gov
DENTSPLY IH Inc.Waltham, MA, United StatesManufacturer2October 25, 2013000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesSpecification developer2March 17, 2022000api.fda.gov
Inosys, Inc.New York, NY, United StatesRepackager or relabeler, Specification developer2June 17, 2026000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer2November 29, 2018000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer2May 28, 2004000api.fda.gov
Newton Implant SystemsVista, CA, United StatesSpecification developer2April 11, 2024000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer2April 7, 2006000api.fda.gov
Suncoast Dental, Inc.Clearwater, FL, United StatesSpecification developer2July 15, 2022000api.fda.gov
Surgikor, LLCLos Angeles, CA, United StatesSpecification developer2July 8, 2019000api.fda.gov
SynorossGlendale, CA, United StatesSpecification developer2May 8, 2025000api.fda.gov
Zuga Medical, Inc.Cleveland, OH, United StatesManufacturer2June 30, 2018000api.fda.gov
Aeton MedicalPennsauken, NJ, United StatesSpecification developer1March 6, 2009000api.fda.gov
Allonrx LLCLafayette, LA, United StatesComplaint file establishment, Specification developer1September 25, 1996000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesSpecification developer1May 5, 2004000api.fda.gov
Dental Evolutions, IncBeverly Hills, CA, United StatesComplaint file establishment, Specification developer1August 27, 2015000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor1April 1, 2020000api.fda.gov
Dmi Technology LLCLynbrook, NY, United StatesSpecification developer1October 3, 2016000api.fda.gov
Emery Enterprises Inc.Irvine, CA, United StatesManufacturer1March 20, 1996000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1December 6, 2010000api.fda.gov
Kat Implants, LLCPortsmouth, NH, United StatesManufacturer1February 23, 2012000api.fda.gov
Louisiana Dental Implant LabLafayette, LA, United StatesSpecification developer1September 25, 1996000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer1October 5, 2023000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer1September 15, 2004000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer1September 15, 2004000api.fda.gov
Trate LLCTamarac, FL, United StatesSpecification developer1April 4, 2022000api.fda.gov
Z7 LLCWhitehouse Station, NJ, United StatesComplaint file establishment, Specification developer1June 26, 2023000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Alien Milling TechnologiesGlendora, CA, United StatesContract manufacturer0000api.fda.gov
Arch Medical& Aerospace- Minneapolis, LLCNew Hope, MN, United StatesContract manufacturer0000api.fda.gov
Barksdale Dental Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
Bayou State Crown & Bridge LabBaton Rouge, LA, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Cleanpac Inc.Birmingham, AL, United StatesContract manufacturer0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Dental CraftersMarshfield, WI, United StatesContract manufacturer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
GCDL, LLCProspect Heights, IL, United StatesContract manufacturer0000api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare Procera, LLCMahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare Usa, LLCYorba Linda, CA, United StatesContract manufacturer0080api.fda.gov
Pan-Am Dental, Inc.Savannah, GA, United StatesContract manufacturer0000api.fda.gov
Precision One MedicalOceanside, CA, United StatesContract manufacturer0000api.fda.gov
Precision One MedicalHoover, AL, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCShakopee, MN, United StatesContract manufacturer0000api.fda.gov
R2 Digital Milling TechnologiesWestwood, NJ, United StatesContract manufacturer0000api.fda.gov
Superior Machined Products, Inc.Oceanside, CA, United StatesContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov

Updated November 2, 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.