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Data / Medical devices / United States / SPFM, L.P.

SPFM, L.P.: FDA-registered device maker in San Antonio, TX, United States, 1 510(k) clearance

SPFM, L.P. is registered with the FDA (registration 3009506228) in San Antonio, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 16, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009506228
FEI number
3004266672
Address
4310 West Ave, San Antonio, TX, United States, 78213
Owner or operator
Ritter Implants GmbH and Co. KG (10039754)
Roles
Repackager or relabeler
First device listed
August 6, 2025
Registered through
2026
Brand names listed
Oral Matrix

Devices it lists

DeviceProduct codeClassRoleSource
Barrier, Animal Source, IntraoralNPL2Repackager or relabeleraccessdata.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 16, 2024K231513Oral MatrixNPLSubstantially EquivalentBeijing Biosis Healing Biolog Ical Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 16, 2024. 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.