510(k) Report

FDA applicant

Osstell AB

Alexandria, VA5 decisions2008–20260 recalls

FDA records 5 decisions for Osstell AB (Alexandria, VA) from 2008 to 2026: 5 510(k) clearances. All are in product code EKX (Handpiece, Direct Drive, Ac-Powered). Its devices cite 6 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 Osstell AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12014: 12015: 12019: 12026 (partial year): 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Osstell AB by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EKXHandpiece, Direct Drive, Ac-Powered5decisions

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K082523Osstell Isq Implant Stability MeterOsstell AB · 20085cite it
  • K181888Osstell BeaconOsstell AB · 20191cites it

What has FDA decided for it lately?

  • K261987Reusable SmartPegOsstell AB · 2026
  • K181888Osstell BeaconOsstell AB · 2019
  • K142358Osstell IDxOsstell AB · 2015
  • K132401Mega IsqOsstell AB · 2014
  • K082523Osstell Isq Implant Stability MeterOsstell AB · 2008

All 5 as Osstell AB →