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Data / Medical devices / United States / Diamodent

Diamodent: FDA-registered device maker in Dana Point, CA, United States, 3 510(k) clearances

Diamodent is registered with the FDA (registration 2031884) in Dana Point, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 30, 2004. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2031884
FEI number
3002832763
Address
35577 Beach Road, Dana Point, CA, United States, 92624
Owner or operator
DiamoDent (9039378)
Roles
Manufacturer, Specification developer
First device listed
April 16, 2008
Registered through
2026
Brand names listed
UCLA

Devices it lists

DeviceProduct codeClassRoleSource
Implant, Endosseous, Root-FormDZE2Manufacturer, Specification developeraccessdata.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
January 30, 2004K034022UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIESDZESubstantially EquivalentDiamodentaccessdata.fda.gov
September 28, 2001K010619UCLA AND UNIVERSAL ABUTMENTSDZESubstantially EquivalentDiamodentaccessdata.fda.gov
March 28, 2000K993129UCLA/UNIVERSAL ABUTMENTDZESubstantially EquivalentDiamodentaccessdata.fda.gov

Compare with other makers

Updated January 30, 2004. 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.