FDA 510(k) Applications Submitted by Blue Sky Bio, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090607 |
03/06/2009 |
BLUE SKY BIO PLAN, VERSION .38 |
BLUE SKY BIO, LLC |
| K051507 |
06/07/2005 |
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K221845 |
06/24/2022 |
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G |
Blue Sky Bio, LLC |
| K102034 |
07/19/2010 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K212785 |
09/01/2021 |
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments |
Blue Sky Bio, LLC |
| K202026 |
07/22/2020 |
Blue Sky Bio CAD-CAM Abutments |
Blue Sky Bio, LLC |
| K110198 |
01/24/2011 |
BLUE SKY BIO TCP |
BLUE SKY BIO, LLC |
| K112875 |
09/30/2011 |
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS |
BLUE SKY BIO, LLC |
| K153064 |
10/22/2015 |
Blue Sky Bio Zygomatic Implant System |
BLUE SKY BIO, LLC |
| K063874 |
12/29/2006 |
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K073713 |
12/31/2007 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K060957 |
04/07/2006 |
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
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