FDA Registration
Active
🇷🇴 Romania
Kulzer SRL
Reg #: 3011203516
·
FEI: 3011203516
·
Expires 2026
Products
4
Proprietary Names
33
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Kulzer SRL
- Registration Number
- 3011203516
- FEI Number
- 3011203516
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Claderia C3, Dietrich Honold 1
- City
- Sacalaz-Judet Timis
- Country
- RO
Owner / Operator
- Firm Name
- Kulzer, LLC
- Operator Number
- 9056636
- Address
- 4315 S. Lafayette Blvd.
- City
- South Bend
- State
- IN
- Postal Code
- 46614
- Country
- US
- Correspondent
- David A Vincent
US Agent
- Business Name
- Kulzer, LLC
- Contact Name
- David Vincent
- Address
- 4315 S Lafayette Blvd
- City
- South Bend
- State
- IN
- ZIP
- 46614
- Country
- US
- [email protected]
- Phone
- 574 2995421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2013-04-11 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2013-04-10 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2006-09-15 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-01-21 |
Proprietary Names
MEMOSIL
Flexitime Bite
Flexitime Dynamix Heavy Tray
Flexitime Dynamix Putty
Flexitime Dynamix Monophase
Flexitime Magnum 360
Palabond
MONDIAL
Mondial I
Paladon 65
Artic Digital
Artic
Pala Digital Denture Tray Refill
Pala Digital Impression Tray
Universal Silicone Adhesive
Pala Digital Denture Starter Kit
Cuttersil Hardener
Flexitime Light Flow
Flexitime Medium Flow
FLEXITIME MONOPHASE PRO SCAN
CUTTERSIL MUCOSA
FLEXITIME XTREME 2
Xantasil
Palpress Vario
Delara
Memoreg 2
Cuttersil Light
Cuttersil Putty Plus
Flexitime Monophase
Flexitime Easy Putty
Flexitime Heavy Tray
Flexitime Correct Flow
Flexitime Unlimited
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)