Facility

Kulzer SRL

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

Key facts

2recalls · worst Class II

2inspections · worst NAI

—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)	3011203516
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Claderia C3 Sacalaz-Judet Timis, RO 30737
Registration status	Active · expires 2026
Parent company	Kulzer, LLC (owner-operator 9056636)
Brand names	Delara

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Denture, Plastic, Teeth
Product code ELM (opens in a new tab) · Class II · Dental · 21 CFR 872.3590

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…

FDA inspections (2)

NAI2019-02-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-09-15
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 SRL (FEI 3011203516) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011203516-kulzer-srl/

Not open yet

Alerts for Kulzer SRL

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.