510(k) Report

FDA applicant

Sdi Limited

Bayswater, AU9 decisions1984–20220 recalls

FDA records 9 decisions for Sdi Limited (Bayswater, AU) from 1984 to 2022: 9 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sdi , Ltd.”, “Sdi”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Sdi Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2007: 12008: 12010: 12018: 12019: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sdi Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sdi Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin3decisions
  • EMACement, Dental2decisions
  • OIVDental Amalgam1decision
  • KLEAgent, Tooth Bonding, Resin1decision
  • PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish1decision
  • KKXDrape, Surgical, Antimicrobial1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222581Stela Automix SystemSdi Limited · 20221cites it

What has FDA decided for it lately?

  • K222581Stela Automix SystemSdi Limited · 2022
  • K222583Stela Capsule SystemSdi Limited · 2022
  • K214118Riva Cem AutomixSdi Limited · 2022
  • K191656ZipbondSdi Limited · 2019
  • K172047Riva StarSdi Limited · 2018
  • K102984AURASdi Limited · 2010
  • K081273Ultracaps SSdi, Ltd. · 2008
  • K073043SET PPSdi, Ltd. · 2007

All 6 as Sdi Limited →All 2 as Sdi, Ltd. →The one decision as Sdi →