Facility

KULZER GMBH

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002807166
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse, DE 61273
Registration status	Active · expires 2026
Parent company	Kulzer, LLC (owner-operator 9056636)
Brand names	Signum Connector

Activity by year

Recalls (2)

Devices registered here (1)

Material, Tooth Shade, Resin
Product code EBF (opens in a new tab) · Class II · Dental · 21 CFR 872.3690

Recalls & enforcement

Class IITerminated2014-04-23
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, …
Class IITerminated2014-02-10
As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Ta…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “KULZER GMBH (FEI 3002807166) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807166-kulzer-gmbh/

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