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Data / Medical devices / Scaler, Ultrasonic / United States

FDA-registered makers of Scaler, Ultrasonic in the United States: 23 establishments

23 establishments in the United States are registered with the FDA to make Scaler, Ultrasonic (product code ELC). 18 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Scaler, Ultrasonic
Product code
ELC
Country
United States

Makers of Scaler, Ultrasonic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Dentsply LLCYork, PA, United StatesManufacturer, Specification developer12June 16, 2015000api.fda.gov
Electro Medical Systems, L.L.C.Southlake, TX, United StatesRemanufacturer, Repackager or relabeler12October 20, 2019000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer, Repackager or relabeler, Specification developer7May 15, 2023000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesContract manufacturer, Manufacturer, Specification developer2August 21, 2006000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer2July 5, 2002000api.fda.gov
Kerr CorporationPomona, CA, United StatesComplaint file establishment, Specification developer2July 5, 2002000api.fda.gov
Sonendo, Inc.Laguna Hills, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2February 5, 2021020api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesRepackager or relabeler, Specification developer2June 5, 2001000api.fda.gov
Aseptico, Inc.Woodinville, WA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export1August 14, 2013000api.fda.gov
Asi Medical, Inc.Englewood, CO, United StatesManufacturer1March 28, 2013000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer1April 22, 1997000api.fda.gov
Dentalez, Inc., Stardental DivisionLancaster, PA, United StatesManufacturer1April 21, 1988010api.fda.gov
Dental Engineering Laboratories, LLCGoleta, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1March 29, 2013000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer1December 11, 2023000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesContract manufacturer, Manufacturer1April 4, 1995000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer1April 17, 2001000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer1May 10, 1996000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler1April 20, 2005000api.fda.gov
American Eagle InstrumentsMissoula, MT, United StatesContract manufacturer0000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer0000api.fda.gov
MedidentaLas Vegas, NV, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.