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Data / Medical devices / Agent, Tooth Bonding, Resin / United States

FDA-registered makers of Agent, Tooth Bonding, Resin in the United States: 41 establishments

41 establishments in the United States are registered with the FDA to make Agent, Tooth Bonding, Resin (product code KLE). 35 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
Agent, Tooth Bonding, Resin
Product code
KLE
Country
United States

Makers of Agent, Tooth Bonding, Resin in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer12January 12, 2023040api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer, Repackager or relabeler10March 17, 2017000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer9September 9, 2016000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer, Specification developer9September 28, 2018000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer8November 21, 2017000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer8December 10, 2003000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler7August 9, 2022000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer7July 8, 2021000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer, Repackager or relabeler5September 21, 2011000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5October 2, 2020000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer5September 6, 2013020api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer5September 21, 2011000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer4March 3, 2026000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer3August 12, 1996000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3July 7, 2000000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer3August 12, 1996000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer3August 12, 1996000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler2October 15, 2018000api.fda.gov
Cao Group, Inc.W Jordan, UT, United StatesComplaint file establishment, Specification developer2October 21, 2009000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer2February 26, 1999000api.fda.gov
Healthdent'l, LLCPlainfield, IL, United StatesManufacturer2September 27, 1995000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer, Repackager or relabeler2January 12, 2023000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer2July 16, 2021000api.fda.gov
Beutlich Pharmaceuticals, LLCBunnell, FL, United StatesRepackager or relabeler, Specification developer1March 23, 1998000api.fda.gov
Biomat Sciences, Inc.Bethesda, MD, United StatesManufacturer1November 15, 1999000api.fda.gov
DMG America LLCEnglewood, NJ, United StatesManufacturer1July 11, 2013000api.fda.gov
Dharma Research/Medeco InternationalMiami, FL, United StatesManufacturer1June 23, 2015000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer1September 1, 2006000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer, Manufacturer1October 30, 1995000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesContract manufacturer, Manufacturer1December 7, 2011000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer1October 25, 1984000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer1October 25, 1984000api.fda.gov
Ribbond, Inc.Racine, WI, United StatesManufacturer, Specification developer1November 23, 2010000api.fda.gov
Temrex Corp.Freeport, NY, United StatesSpecification developer1March 6, 1992000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer1September 2, 2020000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer0000api.fda.gov
Elevate Oral Care, LLCWest Palm Beach, FL, United StatesSpecification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, 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.