FDA applicant

Heraeus Kulzer, Inc., Dental Products Division

South Bend, IN1 decision2008–20080 recalls

FDA records 1 decision for Heraeus Kulzer, Inc., Dental Products Division (South Bend, IN) in 2008: 1 510(k) clearance. All are in product code ELW (Material, Impression). 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 Heraeus Kulzer, Inc., Dental Products Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Heraeus Kulzer, Inc., Dental Products Division by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heraeus Kulzer, Inc., Dental Products…’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

Other applicant names beginning “Heraeus”

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

Heraeus Kulzer, Inc. 170 Heraeus Lasersonics, Inc. 38 Heraeus Medical GmbH 13 Heraeus Surgical, Inc. 8 Heraeus Medical Components, LLC 4 Heraeus Med GmbH 3 Heraeus Dental Gold Corp. 3 Heraeus-Christ GmbH 2 Heraeus Kulzer, LLC (Mitsui Chemicals Group) 2 Heraeus Medical GmbH Technology 1 Heraeus Instruments GmbH 1 Heraeus, Inc. 1

Heraeus Kulzer, Inc., Dental Products Division

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Heraeus”