510(k) Report

FDA applicant

Dentos, Inc.

Ann Arbor, MI2 decisions2006–20190 recalls

FDA records 2 decisions for Dentos, Inc. (Ann Arbor, MI) from 2006 to 2019: 2 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 3 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 Dentos, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dentos, Inc. 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-Form1decision
  • OATImplant, Endosseous, Orthodontic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K060126Absoanchor MicroimplantDentos, Inc. · 20063cite it

What has FDA decided for it lately?

  • K181142Absoanchor MicroimplantDentos, Inc. · 2019
  • K060126Absoanchor MicroimplantDentos, Inc. · 2006

All 2 as Dentos, Inc. →