Blue Sky Bio

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXApril 3, 2024
K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GFebruary 24, 2023
K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporaryJune 30, 2022
K202026Blue Sky Bio CAD-CAM AbutmentsDecember 18, 2020
K201919Blue Sky Bio TADDecember 17, 2020
K190491Blue Sky Bio Zygomatic Implant SystemAugust 12, 2019
K182338Blue Sky Bio Computerized Orthodontic Bracket SystemNovember 9, 2018
K180107Blue Sky Bio AlignerFebruary 9, 2018
K163251Life Essence Universal Porcelain SystemAugust 4, 2017
K153064Blue Sky Bio Zygomatic Implant SystemApril 29, 2016
K112875BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSJanuary 27, 2012
K110198BLUE SKY BIO TCPDecember 22, 2011
K102034BLUE SKY BIO DENTAL IMPLANT SYSTEMApril 19, 2011
K090607BLUE SKY BIO PLAN, VERSION .38April 22, 2009
K073713BLUE SKY BIO DENTAL IMPLANT SYSTEMMarch 28, 2008
K063874DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEMMarch 29, 2007
K060957MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMMay 5, 2006
K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMSeptember 2, 2005
K021833MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEMJune 10, 2002
K010882BLUE SKY BIO DENTAL IMPLANT SYSTEMSeptember 28, 2001