FDA applicant

Osseofuse International, Inc.

Calabasas, CA2 decisions2019–20250 recalls

FDA records 2 decisions for Osseofuse International, Inc. (Calabasas, CA) from 2019 to 2025: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 1 predicate, 1 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 Osseofuse International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Osseofuse International, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Osseofuse”

FDA records each applicant name separately; these may or may not be the same firm.

Osseofuse, Inc. 2

Osseofuse International, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Osseofuse”