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Data / Medical devices / Instruments, Dental Hand / United States

FDA-registered makers of Instruments, Dental Hand in the United States: 79 establishments

79 establishments in the United States are registered with the FDA to make Instruments, Dental Hand (product code DZN). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Instruments, Dental Hand
Product code
DZN
Country
United States

Makers of Instruments, Dental Hand in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1January 3, 1978000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer, Specification developer1August 7, 1980000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Addent, Inc.Danbury, CT, United StatesManufacturer0000api.fda.gov
Allure OrthoWhitinsville, MA, United StatesSpecification developer0000api.fda.gov
American Eagle InstrumentsMissoula, MT, United StatesManufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Aseptico, Inc.Woodinville, WA, United StatesManufacturer for export0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Bicon, LLCBoston, MA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesSpecification developer0000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesContract manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Denovo Dental IncBaldwin Park, CA, United StatesSpecification developer0000api.fda.gov
Dockum Research LabIrwindale, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
DSC Dental, LLCSaint George, UT, United StatesManufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Get-Grin IncAirmont, NY, United StatesSpecification developer0000api.fda.gov
Goldman Products, Inc.Wauconda, IL, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
GoldenDentRoseville, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
H & H Co.Hayden, ID, United StatesContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer0000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
JMS Manufacturing, Inc.Omaha, NE, United StatesContract manufacturer0000api.fda.gov
Jordco, Inc.Hillsboro, OR, United StatesManufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Contract manufacturer, Specification developer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer0000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Nordent MFG., Inc.Elk Grove Village, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nubird Inc.Covington, WA, United StatesManufacturer0000api.fda.gov
Oco BiomedicalAlbuquerque, NM, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Orthonu, LLCRumson, NJ, United StatesManufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
PDT, Inc.Msla, MT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Pru-Dent MFG., Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
PUL & Co.Las Vegas, NV, United StatesSpecification developer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer, Specification developer0000api.fda.gov
Pascal International, Inc.Bellevue, WA, United StatesManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
RC Consolidated Services, IncRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rex Implants, IncColumbus, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
RICOmed ManufacturingRichardson, TX, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Sabra Dental ProductsBohemia, NY, United StatesSpecification developer0000api.fda.gov
Solmetex, LLCNorthborough, MA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Specialty Appliances, LLCCumming, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Suncoast Dental, Inc.Clearwater, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
W.R. Rayson Co., Inc.Burgaw, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
World Class Technology CorporationMcminnville, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Young Microbrush LLCGrafton, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Zirc Dental Products, Inc.Buffalo, MN, United StatesComplaint file establishment, 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.