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SDI LIMITED

Australia Last updated 24 May 2026

Devices
83
Registries
EUDAMED
FDA recalls
11 ongoing

Catalogue83

Page 1 of 2

Showing 1-50 of 83

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FDA recalls1

Device pages show only the recalls that name the device or its 510(k)/PMA.

FDA recall records list 1 recall initiated by SDI LIMITED, initiated on 2026-07-20. By recorded status: 1 ongoing. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2026

    • 20 Jul 2026 Z-2954-2026 Class II Ongoing Potential for electrical discharge from unit when unplugged.

What SDI LIMITED makes

SDI Limited manufactures dental composite resins and related dental products, including the Stela Capsule System, Riva Cem Automix, Zipbond, Riva Star, AURA, and various refill kits and primers.

The company's portfolio includes Class II and Class IIa devices listed in eudamed and fda_510k registries, and is based in Australia.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does SDI LIMITED have in the registry?

The registry currently lists 83 devices for SDI LIMITED. Devices recorded under merged duplicate company entries are counted once.

Which registries list SDI LIMITED's devices?

Among its 50 most recently registered devices, SDI LIMITED has devices listed in EUDAMED (50 devices).

What risk classes do SDI LIMITED's devices fall under?

Among its 50 most recently registered devices, the classes recorded for SDI LIMITED's devices are Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for SDI LIMITED?

FDA recall records list 1 recall initiated by SDI LIMITED, the most recent initiated on 2026-07-20. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from SDI LIMITED in the registry?

The most recently registered devices listed for SDI LIMITED include LUNA FLOW LV 1 SYR A2, LUNA FLOW LV 1 SYR B1, LUNA FLOW LV 1 SYR A3 and LUNA 2 1 SYR A3.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
3-15, Brunsdon, Bayswater, Australia
Phone
+6187277111
PRRC contact
Lyn Chau
EUDAMED SRN
AU-MF-000024633
DUNS number
753221852