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Data / Medical devices / United States / Proma, Inc.

Proma, Inc.: FDA-registered device maker in Carson, CA, United States, 1 510(k) clearance

Proma, Inc. is registered with the FDA (registration 2020475) in Carson, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 1998. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2020475
Address
730 East Kingshill PL., Carson, CA, United States, 90746
Owner or operator
PROMA, INC. (2020475)
Roles
Manufacturer
First device listed
March 25, 1996
Registered through
2026
Brand names listed
A Series, Alliant, DARAY BY PROMA, Domain, Inception

Devices it lists

DeviceProduct codeClassRoleSource
Light, Operating, DentalEAZ1Manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.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
August 3, 1998K980106THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIESEIASubstantially EquivalentProma, Inc.accessdata.fda.gov

Compare with other makers

Updated August 3, 1998. 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.