510(k) Report

FDA applicant

Branemark Integration AB

Goteborg, SE3 decisions2002–20090 recalls

FDA records 3 decisions for Branemark Integration AB (Goteborg, SE) from 2002 to 2009: 3 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 1 predicate, 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 Branemark Integration AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Branemark Integration AB by year, 2007–2026Sources: 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K040643Branemark Integration Dental Implant and AccessoriesBranemark Integration AB · 20041cites it
  • K021355Endosseous ImplantBranemark Integration AB · 20021cites it

What has FDA decided for it lately?

  • K090005Branemark Integration Biohelix ImplantsBranemark Integration AB · 2009
  • K040643Branemark Integration Dental Implant and AccessoriesBranemark Integration AB · 2004
  • K021355Endosseous ImplantBranemark Integration AB · 2002

All 3 as Branemark Integration AB →