510(k) Report

FDA applicant

S.I.N. Implant System Ltda

São Paulo, BR5 decisions2025–20260 recalls

FDA records 5 decisions for S.I.N. Implant System Ltda (São Paulo, BR) from 2025 to 2026: 5 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 S.I.N. Implant System Ltda’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2025: 42026 (partial year): 1
2025high 4 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — S.I.N. Implant System Ltda by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form3decisions
  • NHAAbutment, Implant, Dental, Endosseous1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 184 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K262084S.I.N. Instruments KitsS.I.N. Implant System Ltda · 2026
  • K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda · 2025
  • K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025
  • K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025
  • K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025

All 5 as S.I.N. Implant System Ltda →