Data / Medical devices / Bur, Dental / United States

FDA-registered makers of Bur, Dental in the United States: 38 establishments

Name: FDA-registered makers of Bur, Dental in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

38 establishments in the United States are registered with the FDA to make Bur, Dental (product code EJL). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device: Bur, Dental
Product code: EJL
Country: United States

Makers of Bur, Dental in the United States

Maker	Location	Role	Recall events	Source
Accumedix, Inc.	Libertyville, IL, United States	Contract manufacturer	0	api.fda.gov
American Eagle Instruments	Missoula, MT, United States	Contract manufacturer	0	api.fda.gov
Arnold Tuber Industries	Orchard Park, NY, United States	Manufacturer	0	api.fda.gov
Bicon, LLC	Boston, MA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	1	api.fda.gov
Buffalo Dental MFG. Co., Inc.	Syosset, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Basic Dental Implant Systems, Inc.	Rio Rancho, NM, United States	Manufacturer	0	api.fda.gov
Coltene/Whaledent Inc.	Cuyahoga Falls, OH, United States	Contract manufacturer, Manufacturer	2	api.fda.gov
Cynosure, LLC	Westford, MA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Den-Mat Holdings, LLC	Lompoc, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Dedeco International, Inc.	Long Eddy, NY, United States	Manufacturer	0	api.fda.gov
E. C. Moore Company, Inc.	Dearborn, MI, United States	Manufacturer	0	api.fda.gov
Esthetic Orthodontic Company Of America LLC	St Petersburg, FL, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Icp, Inc.	Green Bay, WI, United States	Specification developer	0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	0	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Microcopy, Division Of Neo-Flo, Inc.	Kennesaw, GA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Nobel Biocare Procera, LLC	Mahwah, NJ, United States	Contract manufacturer	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Manufacturer for export	0	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Power Dental USA, Inc.	McHenry, IL, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Reliance Orthodontic Products, Inc.	Itasca, IL, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
SS White Burs LLC	Lakewood, NJ, United States	Manufacturer	0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	0	api.fda.gov
Ultradent Products Inc.	South Jordan, UT, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Versah LLC	Jackson, MI, United States	Manufacturer	0	api.fda.gov
Versah, LLC	Jackson, MI, United States	Manufacturer	0	api.fda.gov
Zuga Medical, Inc.	Cleveland, OH, United States	Manufacturer	0	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	Manufacturer for export	0	api.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.