FDA Registration
Active
🇺🇸 United States
Blue Sky Bio Dental Implant System - Tri-Lobe
Reg #: 3003402534
·
FEI: 3003402534
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLUE SKY BIO, LLC
- Registration Number
- 3003402534
- FEI Number
- 3003402534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 800 Liberty Drive
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060957
Owner / Operator
- Firm Name
- BLUE SKY BIO, LLC
- Operator Number
- 9040515
- Address
- 800 Liberty Drive
- City
- Libertyville
- State
- IL
- Postal Code
- 60048
- Country
- US
- Correspondent
- Michele - Kupcso
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-11-20 |
Proprietary Names
Blue Sky Bio Dental Implant System - Tri-Lobe
Blue Sky Bio Dental Implant System - Internal Hex
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility