FDA Registration
Active
🇪🇸 Spain
Transporter ceramic
Reg #: 3008808095
·
FEI: 3008808095
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CERAROOT S.L.
- Registration Number
- 3008808095
- FEI Number
- 3008808095
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Parpers 13
- City
- Les Franqueses del Valles Barcelona
- Country
- ES
Owner / Operator
- Firm Name
- CERAROOT S.L.
- Operator Number
- 10034855
- Address
- Parpers 13
- City
- Les Franqueses del Valles
- State
- Barcelona
- Postal Code
- 08520
- Country
- ES
US Agent
- Business Name
- CeraRoot USA Inc.
- Contact Name
- Xavier Oliva
- Address
- 2800 Neilson Way, Suite 2
- City
- Santa Monica
- State
- CA
- ZIP
- 90405
- Country
- US
- [email protected]
- Phone
- 818 4504776
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-11-08 |
Proprietary Names
Transporter ceramic
Torque wrench ratchet
Bur extension
Mallet
Countersink ceramic
Wheel for CeraRoot ratchet
CeraCrown
Handpiece adapter 4x4
Twist drill ceramic
Surgical Tray
CeraRoot
Guided Surgical Tray
Initial bur
Impactor for CR14
Lab Analogue
Wheel for Nobel Biocare ratchet
Transporter steel
Countersink steel
Twist drill steel
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility