FDA Registration
Active
🇺🇸 United States
KULZER, LLC
Reg #: 1821514
·
FEI: 1821514
·
Expires 2026
Products
9
Proprietary Names
28
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- KULZER, LLC
- Registration Number
- 1821514
- FEI Number
- 1821514
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4315 S. Lafayette Blvd.
- City
- SOUTH BEND
- State
- IN
- ZIP
- 46614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K924024
Owner / Operator
- Firm Name
- Kulzer, LLC
- Operator Number
- 9056636
- Address
- 4315 S. Lafayette Blvd.
- City
- South Bend
- State
- IN
- Postal Code
- 46614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2019-03-27 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2019-07-03 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2017-05-31 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 1996-05-13 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2009-08-31 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2026-01-06 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 1994-05-06 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 1996-05-13 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-05-12 |
Proprietary Names
Surgident Periphery Wax
Pala Brillance Denture Cleanser
Venus Rapid Fresh Cleanser
Modern Materials Utility Wax Strips
Modern Materials Bite Blocks
Modern Materials Square Ropes
Utility Square Ropes
Modern Materials Yellow Wax Sheets
Utility Wax Strips
Modern Materials Yellow Check Bite Wafers
Surgident COPRWAX
Cara Scan 4i
Cara Scan 4 BUNDLE
Cara Scan 4
Cara i500
IVORY RUBBER DAM CLAMP
Ivory Rubber Dam Complete Kit
Ivory Rubber Dam Starter Kit
IVORY RUBBER DAM INTRO KIT
Ivory
Ivory Rubber Dam Frame
iCEM Universal Plus
IVORY RUBBER DAM
IVORY RUBBER DAM FORCEPS
Modern Materials Shur Wax Pink
Modern Materials Thin-Ex Wax Pink
Modern Materials Shur Wax X-Hard Pink
Modern Materials Modern Pink No. 3
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198