Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list SDI Limited with 9 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 20, 2026: Dentsply Sirona Capsule Mixer Model No. 5546068.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 20, 2026 | Dentsply Sirona Capsule Mixer Model No. 5546068Class II · Potential for electrical discharge from unit when unplugged. | Device recalls |
| Oct 28, 2022 | Stela Capsule SystemK222583 · EBF | 510(k) clearances |
| Oct 28, 2022 | Stela Automix SystemK222581 · EBF | 510(k) clearances |
| Aug 30, 2022 | Riva Cem AutomixK214118 · EMA | 510(k) clearances |
| Dec 2, 2019 | ZipbondK191656 · KLE | 510(k) clearances |
| Apr 11, 2018 | Riva StarK172047 · PHR | 510(k) clearances |
| Dec 8, 2010 | AURAK102984 · EBF | 510(k) clearances |
| Jul 10, 2008 | ULTRACAPS SK081273 · OIV | 510(k) clearances |
| Dec 14, 2007 | SET PPK073043 · EMA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
