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Data / Medical devices / United States / VITA North America

VITA North America: FDA-registered device maker in Brea, CA, United States, 1 510(k) clearance

VITA North America is registered with the FDA (registration 2082832) in Brea, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 21, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
2082832
Address
1800 E Imperial Hwy Ste 105, Brea, CA, United States, 92821
Owner or operator
VITA North America (2082832)
Roles
Complaint file establishment
First device listed
May 23, 2025
Registered through
2026
Brand names listed
YZ Multi Translucent

Devices it lists

DeviceProduct codeClassRoleSource
Powder, PorcelainEIH2Complaint file establishmentaccessdata.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 21, 2025K243940VITA YZ Multi TranslucentEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov

Compare with other makers

Updated February 21, 2025. 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.