FDA Registration
Active
🇮🇹 Italy
SimpliCore Obturator for Zenflex One
Reg #: 8020994
·
FEI: 1000231788
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Kerr Italia, S.r.l.
- Registration Number
- 8020994
- FEI Number
- 1000231788
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Passanti, 174
- City
- SCAFATI Salerno
- Country
- IT
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1717 W. Collins Ave. Ca. 92867 USA, --
- City
- Orange
- State
- CA
- Postal Code
- 92867
- Country
- US
- Correspondent
- Jennifer Evans
US Agent
- Business Name
- Sybron Dental Specialties
- Contact Name
- Jennifer Evans
- Address
- 1717 W Collins Ave
- City
- Orange
- State
- CA
- ZIP
- 92867
- Country
- US
- [email protected]
- Phone
- 714 5167795
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gutta-Percha | EKM | Class 1 | Dental | No | 2001-01-09 |
Proprietary Names
SimpliCore Obturator for Zenflex One
SimpliCore Obturator Universal
K3XF Gutta Percha
Elements Gutta Percha Cartridge
TF Adaptive Gutta Percha
TF Adaptive Obturator
Gutta Percha Cartridge
TF Adaptive Verifiers
SoftCore
Gutta Percha
Zenflex Pre-Tip Gutta Percha
ZenFlex ONE Gutta Percha
TF Gutta Percha
K3 Gutta Percha
Autofit Gutta Percha
SimpliFill Apical Plugs
Autofit Backfill Gutta Percha
Establishment Types
Manufacture Medical Device