Facility

KULZER, LLC

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

Key facts

2recalls · worst Class II

1inspections · 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)	1821514
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	4315 S. Lafayette Blvd. SOUTH BEND, IN, US 46614
Registration status	Active · expires 2026
Parent company	Kulzer, LLC (owner-operator 9056636)
Brand names	Ivory Rubber Dam Frame; Ivory

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Frame, Rubber Dam
Product code EJE (opens in a new tab) · Class I · Dental · 21 CFR 872.6300

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 (1)

NAI2017-07-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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, LLC (FEI 1821514) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1821514-kulzer-llc/

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