510(k) Report

FDA applicant

Biocoll Laboratories, Inc.

Palm Harobor, FL1 decision1996–19960 recalls

FDA records 1 decision for Biocoll Laboratories, Inc. (Palm Harobor, FL) in 1996: 1 510(k) clearance. All are in product code LYC (Bone Grafting Material, Synthetic). 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 Biocoll Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biocoll Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biocoll Laboratories, 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?

  • LYCBone Grafting Material, Synthetic1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K960267TBM SpongeBiocoll Laboratories, Inc. · 19962cite it

What has FDA decided for it lately?

  • K960267TBM SpongeBiocoll Laboratories, Inc. · 1996

The one decision as Biocoll Laboratories, Inc. →