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Data / Medical devices / Cleanser, Root Canal

Cleanser, Root Canal (KJJ): 21 FDA-registered makers in 4 countries

21 establishments in 4 countries are registered with the FDA to make Cleanser, Root Canal (product code KJJ, Class U). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on July 2, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KJJ
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
United States17
Mexico2
Sweden1
Switzerland1

Makers of Cleanser, Root Canal

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
Inter-Med, Inc.Racine, WI, United StatesManufacturer5August 27, 2024010api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer4February 9, 2018000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer3February 25, 2015000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesSpecification developer3July 25, 2016000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesSpecification developer2October 28, 2011000api.fda.gov
Epien Medical, Inc.White Bear Lake, MN, United StatesComplaint file establishment, Manufacturer2September 9, 2021000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer2March 5, 2003000api.fda.gov
Kerr CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer2March 5, 2003000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer, Specification developer2February 14, 2011000api.fda.gov
Biora ABMALMO Skane, SwedenManufacturer1January 12, 2007000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandSpecification developer1January 12, 2007000api.fda.gov
Jordco, Inc.Hillsboro, OR, United StatesManufacturer1October 14, 1999000api.fda.gov
Oculus Technologies of Mexico, S.A de C.V.Zapopan Jalisco, MexicoComplaint file establishment, Manufacturer1August 18, 2014000api.fda.gov
Sonoma Pharmaceuticals, Inc.Boulder, CO, United StatesManufacturer1August 18, 2014000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Silgan Unicep Packaging, LLC.Sandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesContract manufacturer0000api.fda.gov

Updated July 2, 2025. 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.