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Data / Medical devices / South Africa / Ad Systems And Consulting

Ad Systems And Consulting: FDA-registered device maker in Silver Lakes, Pretoria Gauteng, South Africa, 1 510(k) clearance

Ad Systems And Consulting is registered with the FDA (registration 3015532223) in Silver Lakes, Pretoria Gauteng, South Africa. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015532223
Address
2 Claasens Close, Silver Lakes, Pretoria Gauteng, South Africa, 0054
Owner or operator
AD Systems And Consulting (Pty) Ltd. (10060805)
Roles
Exporter to the US, Manufacturer
First device listed
June 25, 2019
Registered through
2026
Brand names listed
Denture Base Resi n DT20, Xlta Wound Dressing, Zirra Wound Dressing

Devices it lists

DeviceProduct codeClassRoleSource
Dressing, Wound, HydrophilicNAC1Exporter to the US, Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.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
March 31, 2025K250946Denture Base Resin DT20EBISubstantially EquivalentHangzhou SHINING3D Dental Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 31, 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.