FDA Registration
Active
🇺🇸 United States
BLUE SKY BIO, LLC
Reg #: 3003402534
·
FEI: 3003402534
·
Expires 2026
Products
12
Proprietary Names
24
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- BLUE SKY BIO, LLC
- Registration Number
- 3003402534
- FEI Number
- 3003402534
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 800 Liberty Drive
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221845
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 |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2021-05-26 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-07-21 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2023-07-21 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2019-02-06 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-04-03 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2009-05-26 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-03-22 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2006-10-13 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2019-02-06 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2022-06-29 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2014-05-13 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-11-07 |
Proprietary Names
Blue Sky Bio Plan Software - Crown and Bridge Module
Blue Sky Plan Ortho Module
Blue Sky Plan - IBT Module
Blue Sky Bio Dental Implant System
Blue Sky Plan Software
Blue Sky Bio Dental Implant System - Bio / Conus
Blue Sky Bio Pterygoid Implants and Abutments
Zygomatic Implant System
Blue Sky Bio Impression
Blue Sky Bio Dental Implant System - One Piece
Blue Sky Bio Dental Implant System - Internal Taper
Blue Sky Bio Dental Implant System - Internal Octagon Taper
Blue Sky Plan - Denture Module
Blue Sky Bio CAD-CAM Abutments
Blue Sky Bio Dental Implant System - Internal Hex
Blue Sky Bio Dental Implant System - Tri-Lobe
Blue Sky Bio
Blue Sky Bio TAD
Blue Sky Bio Dental Implant System - Double Hex 3 Platform
Blue Sky Bio Dental Implant System - Octagon Regular and Wide Short
Guide Fixation Pin, Parallel Pin Starter
Blue Sky Bio Dental Implant Accessories
Dental Implant Surgical Tray
Blue Sky Plan - Ortho Module
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility