FDA Registration
Active
🇮🇹 Italy
BIOLOREN SRL
Reg #: 3003231822
·
FEI: 3003231822
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BIOLOREN SRL
- Registration Number
- 3003231822
- FEI Number
- 3003231822
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA ALESSANDRO VOLTA 59
- City
- SARONNO Varese
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K061735
Owner / Operator
- Firm Name
- BIOLOREN SRL
- Operator Number
- 9059794
- Address
- VIA ALESSANDRO VOLTA 59, --
- City
- SARONNO
- State
- Varese
- Postal Code
- 21047
- Country
- IT
- Correspondent
- ANDREA - RATTI
US Agent
- Business Name
- Thema Corp
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch St
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2006-07-05 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2003-11-21 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2013-03-19 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2018-06-28 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2011-11-14 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2018-12-20 |
Proprietary Names
INFIBRA
post
FIBER DISK AND BLOCK PERMANENT,
TRILOR
InFibra scissor
Fiber Disks and Blocks
Bioloren drill
Establishment Types
Manufacture Medical Device