FDA applicant

Heraeus Kulzer, LLC (Mitsui Chemicals Group)

South Bend, IN2 decisions2015–20160 recalls

FDA records 2 decisions for Heraeus Kulzer, LLC (Mitsui Chemicals Group) (South Bend, IN) from 2015 to 2016: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). No recall is linked to its devices.

FDA’s records also spell it “Heraeus Kulzer, LLC, Mitsui Chemicals Group”.

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, LLC (Mitsui Chemicals Group)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Heraeus Kulzer, LLC (Mitsui Chemicals Group) by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heraeus Kulzer, LLC (Mitsui Chemicals…’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 Medical GmbH Technology 1 Heraeus Instruments GmbH 1 Heraeus, Inc. 1 Heraeus Kulzer, Inc., Dental Products Division 1

Heraeus Kulzer, LLC (Mitsui Chemicals Group)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Heraeus”