510(k) Report

FDA applicant

Colla-Tec, Inc.

Plainsboro, NJ1 decision1995–19952 recalls

FDA records 1 decision for Colla-Tec, Inc. (Plainsboro, NJ) in 1995: 1 510(k) clearance. All are in product code LYC (Bone Grafting Material, Synthetic). 2 recalls are 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 Colla-Tec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colla-Tec, Inc. since 2007.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Colla-Tec, 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 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.

  • K924408Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 19951cites it

What has FDA decided for it lately?

  • K924408Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 19952 recalls

The one decision as Colla-Tec, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K924408BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an…Mar 28, 2013Class II
  • K924408OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an…Mar 28, 2013Class II