FDA applicant

Sulzer Calcitek, Inc.

Carlsbad, CA9 decisions1997–20010 recalls

FDA records 9 decisions for Sulzer Calcitek, Inc. (Carlsbad, CA) from 1997 to 2001: 9 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and EBF (Material, Tooth Shade, Resin). 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 Sulzer Calcitek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sulzer Calcitek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sulzer”

FDA records each applicant name separately; these may or may not be the same firm.

Sulzer Orthopedics, Inc. 45 Sulzer Dental, Inc. 9 Sulzer Spine-Tech 8 Sulzer Intratherapeutics, Inc. 8 Sulzer Carbomedics, Inc. 8 Sulzer Oscor, Inc. 2

Sulzer Calcitek, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sulzer”