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Data / Medical devices / Unit, Operative Dental / United States

FDA-registered makers of Unit, Operative Dental in the United States: 34 establishments

34 establishments in the United States are registered with the FDA to make Unit, Operative Dental (product code EIA). 23 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Unit, Operative Dental
Product code
EIA
Country
United States

Makers of Unit, Operative Dental in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A-dec, Inc.Newberg, OR, United StatesComplaint file establishment, Manufacturer, Specification developer11March 2, 2022000api.fda.gov
Anodia SystemsDanville, KY, United StatesManufacturer, Repackager or relabeler, Specification developer3June 19, 2003000api.fda.gov
Aseptico, Inc.Woodinville, WA, United StatesComplaint file establishment, Manufacturer3April 11, 2011000api.fda.gov
Carestream Dental LLCAtlanta, GA, United StatesComplaint file establishment, Specification developer2November 10, 2011000api.fda.gov
DCI International, LLCNewberg, OR, United StatesManufacturer2February 19, 2025000api.fda.gov
Midmark CorporationVersailles, OH, United StatesManufacturer2November 3, 2025000api.fda.gov
Sota Precision Optics, Inc.Orange, CA, United StatesManufacturer2May 23, 2006000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesManufacturer, Repackager or relabeler, Specification developer2September 15, 1998000api.fda.gov
Asi Medical, Inc.Englewood, CO, United StatesManufacturer1April 5, 2012010api.fda.gov
Boyd Industries, Inc.Clearwater, FL, United StatesManufacturer1August 8, 2002000api.fda.gov
Dentalez Of AlabamaBay Minette, AL, United StatesComplaint file establishment, Manufacturer1July 8, 1993000api.fda.gov
Digital Doc LLCEl Dorado Hills, CA, United StatesManufacturer, Remanufacturer1August 10, 1998000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer1March 23, 2004000api.fda.gov
Dentsply Sirona Orthodontics Inc.Richardson, TX, United StatesSpecification developer1November 16, 2000000api.fda.gov
Ergonomic Products, Inc.Fall River, MA, United StatesManufacturer1April 18, 2014000api.fda.gov
Forest Dental EquipmentBay Minette, AL, United StatesContract manufacturer, Manufacturer1August 17, 2018000api.fda.gov
Genesis Dental Technologies, LLCElmwood, WI, United StatesManufacturer1June 2, 1994000api.fda.gov
Lares ResearchChico, CA, United StatesManufacturer1December 15, 2022000api.fda.gov
Metrex ResearchRomulus, MI, United StatesManufacturer1May 23, 1995000api.fda.gov
Proma, Inc.Carson, CA, United StatesManufacturer1August 3, 1998000api.fda.gov
Steri-Shield IncorporatedFernandina Beach, FL, United StatesManufacturer, Specification developer1March 17, 1989000api.fda.gov
Summit Dental Systems LLC.Fort Lauderdale, FL, United StatesManufacturer1October 1, 1986000api.fda.gov
SterisilColorado Spgs, CO, United StatesManufacturer, Repackager or relabeler1October 30, 2003000api.fda.gov
Beaverstate Dental, Inc.Newberg, OR, United StatesManufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
Biotec, Inc.Zeeland, MI, United StatesManufacturer0000api.fda.gov
Microgenics CorporationFremont, CA, United StatesManufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Proedge Dental ProductsCentennial, CO, United StatesManufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer0000api.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.