Blue Sky Bio, LLC
Libertyville, IL, US
BLUE SKY BIO, LLC appears in FDA device records in Libertyville, IL. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Blue Sky Bio, LLC between 2000 and 2024. The busiest year on record is 2011, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | NXC | Substantially Equivalent | |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | NXC | Substantially Equivalent | |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | DZE | Substantially Equivalent | |
| K202026 | Blue Sky Bio CAD-CAM Abutments | NHA | Substantially Equivalent | |
| K201919 | Blue Sky Bio TAD | OAT | Substantially Equivalent | |
| K190491 | Blue Sky Bio Zygomatic Implant System | NHA | Substantially Equivalent | |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | DYW | Substantially Equivalent | |
| K180107 | Blue Sky Bio Aligner | NXC | Substantially Equivalent | |
| K163251 | Life Essence Universal Porcelain System | EIH | Substantially Equivalent | |
| K153064 | Blue Sky Bio Zygomatic Implant System | DZE | Substantially Equivalent | |
| K112875 | BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS | DZE | Substantially Equivalent | |
| K110198 | BLUE SKY BIO TCP | LYC | Substantially Equivalent | |
| K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K090607 | BLUE SKY BIO PLAN, VERSION .38 | LLZ | Substantially Equivalent | |
| K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K063874 | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K010882 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | LYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003402534 | 3003402534 | BLUE SKY BIO, LLC | 800 Liberty Drive, Libertyville, IL 60048 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth
- NXCAligner, Sequential
- LYCBone Grafting Material, Synthetic
- DYWBracket, Plastic, Orthodontic
- OATImplant, Endosseous, Orthodontic
- DZEImplant, Endosseous, Root-Form
- PNNOrthodontic Software
- EBLPin, Retentive And Splinting, And Accessory Instruments
- EIHPowder, Porcelain
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- EHYTray, Impression, Preformed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain