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Data / Medical devices / Tray, Impression, Preformed / United States

FDA-registered makers of Tray, Impression, Preformed in the United States: 51 establishments

51 establishments in the United States are registered with the FDA to make Tray, Impression, Preformed (product code EHY). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Tray, Impression, Preformed
Product code
EHY
Country
United States

Makers of Tray, Impression, Preformed in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Advantage Dental Products, Inc.Clarkston, MI, United StatesManufacturer0000api.fda.gov
Advantech Plastics, LLCWoodstock, IL, United StatesManufacturer0000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Arnold Tuber IndustriesOrchard Park, NY, United StatesManufacturer0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Aurum Ceramic Dental Laboratories LLCSpokane, WA, United StatesManufacturer0000api.fda.gov
Ada Products Company, LLCNew Franken, WI, United StatesManufacturer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer0000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesManufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesManufacturer0000api.fda.gov
Dentca, Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer, Specification developer0000api.fda.gov
G & H Wire CompanyFranklin, IN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesManufacturer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesSpecification developer0000api.fda.gov
Ivoclar Vivadent, Inc.Amherst, NY, United StatesSpecification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jardon Eye Prosthetics, Inc.Southfield, MI, United StatesManufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Dental Lab, LLCAntioch, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Orthopli Corp.Philadelphia, PA, United StatesManufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Precision Dental Products, LLCDraper, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Smart Denture Conversions, LLCApex, NC, United StatesManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Contract manufacturer, Specification developer0000api.fda.gov
Special Projects Engineering IncMason, MI, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer for export, Specification developer0000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer0000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0000api.fda.gov
Vamco, LLCAlbuquerque, NM, United StatesManufacturer0000api.fda.gov
World Lab U.S.A.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesSpecification developer0000api.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.