FDA applicant

Kulzer, Inc.

Chicago, IL38 decisions1981–20260 recalls

FDA records 38 decisions for Kulzer, Inc. (Chicago, IL) from 1981 to 2026: 38 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBZ (Activator, Ultraviolet, For Polymerization). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kulzer, 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 Kulzer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007high 2 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kulzer, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Kulzer, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?