510(k) Report

FDA applicant

Osseous Technologies of America

San Diego, CA1 decision2008–20080 recalls

FDA records 1 decision for Osseous Technologies of America (San Diego, CA) in 2008: 1 510(k) clearance. All are in product code NPL (Barrier, Animal Source, Intraoral). 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 Osseous Technologies of America’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 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 — Osseous Technologies of America by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osseous Technologies of America’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NPLBarrier, Animal Source, Intraoral1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K073685Ota Collagen BiomaterialOsseous Technologies of America · 20081cites it

What has FDA decided for it lately?

  • K073685Ota Collagen BiomaterialOsseous Technologies of America · 2008

The one decision as Osseous Technologies of America →