FDA applicant

Bicon, Inc.

Boston, MA18 decisions1997–20150 recalls

FDA records 18 decisions for Bicon, Inc. (Boston, MA) from 1997 to 2015: 18 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and EBF (Material, Tooth Shade, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bicon, LLC”.

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 Bicon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bicon, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bicon, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?