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Data / Medical devices / Agent, Polishing, Abrasive, Oral Cavity / United States

FDA-registered makers of Agent, Polishing, Abrasive, Oral Cavity in the United States: 38 establishments

38 establishments in the United States are registered with the FDA to make Agent, Polishing, Abrasive, Oral Cavity (product code EJR). 10 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
Agent, Polishing, Abrasive, Oral Cavity
Product code
EJR
Country
United States

Makers of Agent, Polishing, Abrasive, Oral Cavity in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer3November 12, 1987000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2April 12, 2007000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer2November 12, 1987000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 17, 1980000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer1July 2, 1987000api.fda.gov
Dentsply LLCYork, PA, United StatesManufacturer, Specification developer1August 6, 2012000api.fda.gov
Electro Medical Systems, L.L.C.Southlake, TX, United StatesRemanufacturer, Repackager or relabeler1September 11, 2017000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer1October 26, 2004000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer1November 21, 2006000api.fda.gov
Preventive Technologies, Inc.Indian Trail, NC, United StatesManufacturer, Specification developer1June 17, 2010000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesSpecification developer0000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Dedeco International, Inc.Long Eddy, NY, United StatesManufacturer0000api.fda.gov
Dharma Research/Medeco InternationalMiami, FL, United StatesManufacturer0000api.fda.gov
E. C. Moore Company, Inc.Dearborn, MI, United StatesManufacturer0000api.fda.gov
GreenMark Biomedical LabAnn Arbor, MI, United StatesManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer0000api.fda.gov
Medental Intl.Vista, CA, United StatesSpecification developer0000api.fda.gov
Medical Products Laboratories, Inc.Philadelphia, PA, United StatesContract manufacturer0000api.fda.gov
Nomax, Inc.Affton, MO, United StatesContract manufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov
Pascal International, Inc.Bellevue, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Prisman, Inc.Beaver, PA, United StatesSpecification developer0000api.fda.gov
Reko Dental, LLCGardena, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SKY DENT Corp for dental tradingNew York, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONSGreenville, SC, United StatesContract manufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
VH Technologies Ltd.Lynnwood, WA, United StatesManufacturer0000api.fda.gov
Viarden Lab LLCMission, TX, United StatesManufacturer0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesSpecification developer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesContract manufacturer, Manufacturer0010api.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.