FDA applicant

Calcitek, Inc.

Carlsbad, CA21 decisions1984–19970 recalls

FDA records 21 decisions for Calcitek, Inc. (Carlsbad, CA) from 1984 to 1997: 21 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and 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 Calcitek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Calcitek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Calcitek, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?