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Blue Sky Bio, LLC

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXNXC2024-04-03 View
510(k) K221845 Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXC2023-02-24 View
510(k) K212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsDZE2022-06-30 View
510(k) K202026 Blue Sky Bio CAD-CAM AbutmentsNHA2020-12-18 View
510(k) K201919 Blue Sky Bio TADOAT2020-12-17 View
510(k) K190491 Blue Sky Bio Zygomatic Implant SystemNHA2019-08-12 View
510(k) K180107 Blue Sky Bio AlignerNXC2018-02-09 View
510(k) K153064 Blue Sky Bio Zygomatic Implant SystemDZE2016-04-29 View
510(k) K112875 BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSDZE2012-01-27 View
510(k) K110198 BLUE SKY BIO TCPLYC2011-12-22 View
510(k) K102034 BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2011-04-19 View
510(k) K090607 BLUE SKY BIO PLAN, VERSION .38LLZ2009-04-22 View
510(k) K073713 BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2008-03-28 View
510(k) K063874 DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2007-03-29 View
510(k) K060957 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2006-05-05 View
510(k) K051507 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2005-09-02 View
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