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Data / Medical devices / United States / United Dental Resources Corporation

United Dental Resources Corporation: FDA-registered device maker in University Park, IL, United States, 3 510(k) clearances

United Dental Resources Corporation is registered with the FDA (registration 3015194291) in University Park, IL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015194291
Address
80 Towncenter Dr, University Park, IL, United States, 60484
Owner or operator
United Dental Resources Corporation (10059448)
Roles
Contract manufacturer, Manufacturer
First device listed
January 30, 2019
Registered through
2026
Brand names listed
Abutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Hybrid, Abutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Titanium, Abutment, Implant, Dental, Endosseous - Preat Abutments, GenesisZr 4Y Zirconia, GenesisZr 4Y+ (ST1100) Zirconi, GenesisZr UHT700 Zirconia

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 23, 2021K201915GenesisZr 4Y+ (ST1100) ZirconiaEIHSubstantially EquivalentUnited Dental Resources Corporationaccessdata.fda.gov
January 28, 2021K201608GenesisZr UHT700 ZirconiaEIHSubstantially EquivalentUnited Dental Resources Corporationaccessdata.fda.gov
January 25, 2019K182642GenesisZr™ 4Y ZirconiaEIHSubstantially EquivalentUnited Dental Resources Corporationaccessdata.fda.gov

Compare with other makers

Updated February 23, 2021. 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.