FDA 510(k) Applications Submitted by ALBERT ZICKMANN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180107 |
01/16/2018 |
Blue Sky Bio Aligner |
Blue Sky Bio LLC |
| K090607 |
03/06/2009 |
BLUE SKY BIO PLAN, VERSION .38 |
BLUE SKY BIO, LLC |
| K010882 |
03/23/2001 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO |
| K021833 |
06/04/2002 |
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM |
BLUE SKY BIO |
| 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 |
| K182338 |
08/28/2018 |
Blue Sky Bio Computerized Orthodontic Bracket System |
Blue Sky Bio |
| K232653 |
08/31/2023 |
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX |
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 |
| K163251 |
11/18/2016 |
Life Essence Universal Porcelain System |
BLUE SKY BIO |
|
|
