FDA applicant

Sigmagraft, Inc.

Fullerton, CA3 decisions2015–20230 recalls

FDA records 3 decisions for Sigmagraft, Inc. (Fullerton, CA) from 2015 to 2023: 3 510(k) clearances. Most are in product codes NPM (Bone Grafting Material, Animal Source) and NPL (Barrier, Animal Source, Intraoral). 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 Sigmagraft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2015high 2 (2023) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Sigmagraft, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sigmagraft, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?