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Data / Medical devices / Material, Tooth Shade, Resin / United States

FDA-registered makers of Material, Tooth Shade, Resin in the United States: 47 establishments

47 establishments in the United States are registered with the FDA to make Material, Tooth Shade, Resin (product code EBF). 41 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
Material, Tooth Shade, Resin
Product code
EBF
Country
United States

Makers of Material, Tooth Shade, Resin in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer28August 31, 2022070api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer16April 1, 2016000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer15December 17, 2024000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler15November 22, 2019000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer13September 27, 2016000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer12June 13, 2022000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer12June 13, 2022000api.fda.gov
Solventum US LLCIrvine, CA, United StatesContract manufacturer, Manufacturer12June 13, 2022000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler12July 1, 2026020api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler11October 15, 2024000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesManufacturer, Repackager or relabeler10July 2, 1996000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer10August 23, 1991000api.fda.gov
Kerr CorporationPomona, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer9August 31, 2022000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer9August 28, 2015000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer, Repackager or relabeler8August 28, 2015000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer7March 7, 2007000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer, Repackager or relabeler7October 1, 2009000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer5November 7, 2002000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer, Repackager or relabeler4December 14, 2018000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer4November 7, 2025000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer4July 20, 2021000api.fda.gov
Denali R & D CorporationHanover, MA, United StatesComplaint file establishment, Specification developer3February 26, 2016000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer3May 30, 2025000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer3May 25, 2022000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer3April 15, 2026000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesSpecification developer3April 15, 2026000api.fda.gov
Bicon, LLCBoston, MA, United StatesManufacturer2June 2, 2015000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer2November 17, 2015000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer2November 16, 2016000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer2August 17, 2000000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer2October 5, 1990000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer, Repackager or relabeler2July 26, 2021000api.fda.gov
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital DentalScottsdale, AZ, United StatesSpecification developer1February 24, 2018000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor1August 16, 2022000api.fda.gov
Dentsply LLCYork, PA, United StatesManufacturer for export, Specification developer1June 10, 1994000api.fda.gov
George Taub Products & Fusion Co., Inc.Jersey City, NJ, United StatesManufacturer1February 26, 2016000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer1September 8, 2006000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer, Manufacturer1August 28, 2000000api.fda.gov
Ribbond, Inc.Racine, WI, United StatesManufacturer, Specification developer1May 3, 2002000api.fda.gov
Smart Denture Conversions, LLCApex, NC, United StatesRepackager or relabeler, Specification developer1February 24, 2018000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1April 30, 1997000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Harvest Dental Products LLCBrea, CA, United StatesManufacturer0000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer0000api.fda.gov
Idoc Dental LabOrange, CA, United StatesContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Oxford Performance Materials, Inc.South Windsor, CT, United StatesContract manufacturer0000api.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.