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Data / Medical devices / Cement, Dental / United States

FDA-registered makers of Cement, Dental in the United States: 36 establishments

36 establishments in the United States are registered with the FDA to make Cement, Dental (product code EMA). 34 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
Cement, Dental
Product code
EMA
Country
United States

Makers of Cement, Dental in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Jersey Dental SuppliesLakewood, NJ, United StatesRepackager or relabeler, Reprocessor39February 6, 2017000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler16November 24, 2020000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer11March 29, 2013000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer9May 5, 2011000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer9May 5, 2011000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer9May 5, 2011000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer7April 2, 2024000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer7September 7, 2005000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler7July 13, 2021000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesComplaint file establishment, Contract manufacturer, Manufacturer6July 11, 2025010api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer6October 11, 2019000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer, Specification developer6September 7, 2005000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5November 9, 1999000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer5January 20, 2022000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3January 15, 2009000api.fda.gov
Denali R & D CorporationHanover, MA, United StatesComplaint file establishment, Specification developer3November 10, 2014000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer3December 19, 2022000api.fda.gov
George Taub Products & Fusion Co., Inc.Jersey City, NJ, United StatesManufacturer, Repackager or relabeler3November 10, 2014000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3September 10, 2015080api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer, Repackager or relabeler3August 7, 2026000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer3July 22, 2015000api.fda.gov
Doc Brands, Inc.Knoxville, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2March 21, 2003000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer, Repackager or relabeler2April 15, 2026000api.fda.gov
Nusmile, LtdHouston, TX, United StatesRepackager or relabeler, Specification developer2June 20, 2025000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer2January 8, 1999000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer, Manufacturer1August 17, 2015000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1December 10, 1998000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer1December 10, 1998000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer1April 16, 1990000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer1April 16, 1990000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer1January 23, 2012000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer1January 21, 1994000api.fda.gov
Steiner BiotechnologyHenderson, NV, United StatesManufacturer1June 6, 2016000api.fda.gov
Viarden Lab LLCMission, TX, United StatesManufacturer for export, Repackager or relabeler1January 23, 2012000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer0000api.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.