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Data / Medical devices / Resin, Denture, Relining, Repairing, Rebasing / United States

FDA-registered makers of Resin, Denture, Relining, Repairing, Rebasing in the United States: 54 establishments

54 establishments in the United States are registered with the FDA to make Resin, Denture, Relining, Repairing, Rebasing (product code EBI). 37 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
Resin, Denture, Relining, Repairing, Rebasing
Product code
EBI
Country
United States

Makers of Resin, Denture, Relining, Repairing, Rebasing in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler18March 3, 2016000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer9May 20, 2025000api.fda.gov
Lang Dental MFG. Co., Inc.Wheeling, IL, United StatesComplaint file establishment, Manufacturer7September 2, 2016010api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer6December 17, 2024000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler6October 24, 2024010api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer4October 24, 2024000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler4August 27, 2026000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer4April 29, 2025000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesSpecification developer4April 29, 2025000api.fda.gov
ST. George Technology, Inc.Wilmington, NC, United StatesSpecification developer4February 10, 2000000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer3November 4, 2011000api.fda.gov
Myerson LLCChicago, IL, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler3April 13, 2023000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer3January 26, 2006000api.fda.gov
Thermoplastic Comfort Systems, Inc.Signal Hill, CA, United StatesComplaint file establishment, Manufacturer3February 3, 2015000api.fda.gov
Dentca, Inc.Irvine, CA, United StatesManufacturer2November 17, 2022000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer2January 25, 2002000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer2June 20, 2024000api.fda.gov
Ribbond, Inc.Racine, WI, United StatesManufacturer, Specification developer2January 25, 2002000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer2September 22, 1999000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer2June 16, 2014000api.fda.gov
Carbon, Inc.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer1June 2, 2026000api.fda.gov
CFS Dental IncHialeah, FL, United StatesManufacturer, Repackager or relabeler1January 22, 2009000api.fda.gov
Comfort Acrylics, Inc.Camas, WA, United StatesManufacturer1May 15, 1990000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer1October 12, 2007000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer1June 16, 2014000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer1July 8, 2026000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesComplaint file establishment, Manufacturer1July 8, 2026000api.fda.gov
Harvest Dental Products LLCBrea, CA, United StatesManufacturer1August 16, 2023000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer1June 20, 2024000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesRemanufacturer, Repackager or relabeler1June 30, 2017000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer1June 6, 2006000api.fda.gov
JBC And CompanyFredericksburg, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler1February 24, 1998000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer1November 25, 2025000api.fda.gov
Pan-Am Dental, Inc.Sandy, UT, United StatesManufacturer1April 16, 1990000api.fda.gov
Reliance Dental MFG., LLCAlsip, IL, United StatesManufacturer1September 23, 1985000api.fda.gov
Talon Acrylics, Inc.Winchester, OR, United StatesManufacturer, Repackager or relabeler, Reprocessor1August 2, 2007000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer1June 20, 2024000api.fda.gov
Bicon, LLCBoston, MA, United StatesManufacturer0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesManufacturer0000api.fda.gov
Co-Oral-Ite Dental MFG. Co.Diamond Springs, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Davis Dental LabWyoming, MI, United StatesContract manufacturer0000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor0000api.fda.gov
Esstech, IncEssington, PA, United StatesContract manufacturer0000api.fda.gov
Fricke Dental MFG. Co.Streamwood, IL, United StatesManufacturer0000api.fda.gov
Idoc Dental LabOrange, CA, United StatesContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Myohealth Technologies, LLCPortland, OR, United StatesManufacturer0000api.fda.gov
Somnomed Inc.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Valplast Intl. Corp.E Northport, NY, United StatesManufacturer0000api.fda.gov
Vynacron Dental Resins, Inc.Jackson, NJ, United StatesManufacturer0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer0000api.fda.gov
Yates-MotloidElmhurst, IL, 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.