Blue Sky Bio, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Blue Sky Bio, LLC - FDA 510(k) Cleared Devices
Recent clearances: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX, Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G, Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
16
Total
16
Cleared
0
Denied
Blue Sky Bio, LLC has 16 FDA 510(k) cleared dental devices. Based in Grayslake, US.
Latest FDA clearance: Apr 2024. Active since 2005.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by PaxMed International, LLC, Third Party Review Group, LLC and Compliance4Devices.
FDA 510(k) Regulatory Record - Blue Sky Bio, LLC
16 devices
Cleared
Apr 03, 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
Dental
216d
Cleared
Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Dental
245d
Cleared
Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue...
Dental
302d
Cleared
Dec 18, 2020
Blue Sky Bio CAD-CAM Abutments
Dental
149d
Cleared
Dec 17, 2020
Blue Sky Bio TAD
Dental
160d
Cleared
Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
Dental
165d
Cleared
Feb 09, 2018
Blue Sky Bio Aligner
Dental
24d
Cleared
Apr 29, 2016
Blue Sky Bio Zygomatic Implant System
Dental
190d
Cleared
Jan 27, 2012
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
Dental
119d
Cleared
Dec 22, 2011
BLUE SKY BIO TCP
Dental
332d
Cleared
Apr 19, 2011
BLUE SKY BIO DENTAL IMPLANT SYSTEM
Dental
274d
Cleared
Apr 22, 2009
BLUE SKY BIO PLAN, VERSION .38
Radiology
47d