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Data / Medical devices / Sealant, Pit And Fissure, And Conditioner / United States

FDA-registered makers of Sealant, Pit And Fissure, And Conditioner in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Sealant, Pit And Fissure, And Conditioner (product code EBC). 19 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
Sealant, Pit And Fissure, And Conditioner
Product code
EBC
Country
United States

Makers of Sealant, Pit And Fissure, And Conditioner in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Dentsply LLCYork, PA, United StatesSpecification developer5August 20, 1999000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer5February 8, 2006000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer4August 18, 2023010api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer3October 16, 1992000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer2November 24, 1981000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer2October 8, 1999000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer2October 8, 1999000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer2October 8, 1999000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesManufacturer1January 28, 1988000api.fda.gov
Denali R & D CorporationHanover, MA, United StatesComplaint file establishment, Specification developer1June 5, 2007000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer1April 23, 1990000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer1November 8, 2019000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1January 4, 1996000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer1September 4, 2003000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer1September 8, 2017000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer1August 8, 2025000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer1October 18, 2016000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer1November 1, 2001000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer1February 13, 1989000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.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.