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Data / Medical devices / Varnish, Cavity / United States

FDA-registered makers of Varnish, Cavity in the United States: 36 establishments

36 establishments in the United States are registered with the FDA to make Varnish, Cavity (product code LBH). 29 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 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.

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Device
Varnish, Cavity
Product code
LBH
Country
United States

Makers of Varnish, Cavity in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ultradent Products Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer6April 30, 2026010api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer5February 12, 1999000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer3December 9, 2011000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer3May 10, 2023000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer3May 10, 2023000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler3May 20, 2016020api.fda.gov
Centrix, Inc.Shelton, CT, United StatesRepackager or relabeler, Specification developer2November 21, 2025000api.fda.gov
Colgate-Palmolive CompanyPiscataway, NJ, United StatesComplaint file establishment, Specification developer2November 1, 2013000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer2September 18, 2013000api.fda.gov
Elevate Oral Care, LLCWest Palm Beach, FL, United StatesComplaint file establishment, Manufacturer, Specification developer2July 18, 2024000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer2November 21, 2006000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer, Repackager or relabeler2May 10, 2023000api.fda.gov
Advantage Dental Products, Inc.Clarkston, MI, United StatesManufacturer1November 17, 1999000api.fda.gov
Cao Group, Inc.W Jordan, UT, United StatesComplaint file establishment, Specification developer1May 25, 2007000api.fda.gov
Cumberland Biotherapeutics, LLC.Sewanee, TN, United StatesSpecification developer1October 2, 2008000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1September 18, 2013000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer1December 19, 2007000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer1October 15, 2012000api.fda.gov
Discus Dental, LLCOntario, CA, United StatesManufacturer1January 10, 2007010api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesComplaint file establishment, Specification developer1January 8, 2025000api.fda.gov
Kenvue Brands LLCSummit, NJ, United StatesSpecification developer1January 29, 2015000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer1January 7, 1994010api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer, Manufacturer for export1September 22, 2014000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer1June 13, 2024000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer1January 10, 2007000api.fda.gov
Preventive Technologies, Inc.Indian Trail, NC, United StatesManufacturer1December 12, 2014000api.fda.gov
Pascal International, Inc.Bellevue, WA, United StatesManufacturer, Repackager or relabeler1May 2, 2003000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer1June 20, 1985000api.fda.gov
Tom's of Maine, Inc.Sanford, ME, United StatesManufacturer1September 13, 2011000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Cetylite Industries, Inc.Pennsauken, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Medical Products Laboratories, Inc.Philadelphia, PA, United StatesContract manufacturer0000api.fda.gov
O&S Dental, Inc.Chicago, IL, United StatesManufacturer for export0000api.fda.gov
Silgan Unicep Packaging, LLC.Sandpoint, ID, United StatesContract manufacturer0000api.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.