Contract manufacturerKULZER, LLC (South Bend, IN)IndianaDentalClass I
KULZER, LLC
Contract manufacturer ยท South Bend, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1821514 (openFDA record; or search FDA's registration database)
- FEI number
- 1821514
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Kulzer, LLC (FDA owner/operator no. 9056636)
- Registered address
- 4315 S. Lafayette Blvd., South Bend, IN 46614
- Contract listings
- 5 device listings, 5 product codes, first listed May 13, 1996
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EEF | Clamp, Rubber Dam | Class I | Dental | Contract manufacturing | May 13, 1996 |
| EFT | Cleanser, Denture, Over The Counter | Class I | Dental | Contract manufacturing | Jul 3, 2019 |
| EGD | Wax, Dental, Intraoral | Class I | Dental | Contract manufacturing | May 13, 1996 |
| EJE | Frame, Rubber Dam | Class I | Dental | Contract manufacturing | Aug 31, 2009 |
| EJG | Forceps, Rubber Dam Clamp | Class I | Dental | Contract manufacturing | May 13, 1996 |