510(k) Report

FDA applicant

Sic Invent AG

Basel, CH5 decisions2005–20260 recalls

FDA records 5 decisions for Sic Invent AG (Basel, CH) from 2005 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 265 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 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 Sic Invent AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12022: 12026 (partial year): 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sic Invent AG’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?

  • DZEImplant, Endosseous, Root-Form4decisions
  • NHAAbutment, Implant, Dental, Endosseous1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K173207SIC invent Dental Implant SystemsSic Invent AG · 20182cite it
  • K040757Sic ProSic Invent AG · 20052cite it
  • K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 20061cites it

What has FDA decided for it lately?

  • K252904SIC Abutments including CAD/CAM SolutionsSic Invent AG · 2026
  • K210489SICtapered & SICvantage taperedSic Invent AG · 2022
  • K173207SIC invent Dental Implant SystemsSic Invent AG · 2018
  • K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
  • K040757Sic ProSic Invent AG · 2005

All 5 as Sic Invent AG →