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Data / Medical devices / Wax, Dental, Intraoral / United States

FDA-registered makers of Wax, Dental, Intraoral in the United States: 37 establishments

37 establishments in the United States are registered with the FDA to make Wax, Dental, Intraoral (product code EGD). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Wax, Dental, Intraoral
Product code
EGD
Country
United States

Makers of Wax, Dental, Intraoral in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Garreco, LLCHeber Springs, AR, United StatesManufacturer7August 21, 1991000api.fda.gov
Kulzer, LLCSouth Bend, IN, United StatesContract manufacturer, Manufacturer2November 17, 1992000api.fda.gov
Advanced Dental DesignsMoreno Valley, CA, United StatesManufacturer0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Asap LLCSanta Fe Spgs, CA, United StatesManufacturer0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
DenTek Oral Care, Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Freeman Manufacturing & Supply Co.Avon, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Gurunanda LLCBuena Park, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer0000api.fda.gov
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Kent Manufacturing CompanyGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesSpecification developer0000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Memphis Dental MFG. Co., Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
O&S Dental, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Orvance, LLCCaledonia, MI, United StatesSpecification developer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ranir LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Reko Dental, LLCGardena, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rosemarie Products Company, LLCMason, OH, United StatesSpecification developer0000api.fda.gov
Sagemax Bioceramics, Inc.Federal Way, WA, United StatesSpecification developer0000api.fda.gov
ST. George Technology, Inc.Wilmington, NC, United StatesSpecification developer0000api.fda.gov
Sunstar Americas, Inc.Schaumburg, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer0000api.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.