RegWardenFDA facility compliance records
Facility

KULZER GMBH

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

Activity by year

FDA actions on record by year2014: 2 recalls2’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Devices registered here (1)

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…

Related

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 3006610834) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006610834-kulzer-gmbh/

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