510(k) K212785

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments by Blue Sky Bio, LLC — Product Code DZE

K212785 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments". The FDA issued a decision of Substantially Equivalent on June 30, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Blue Sky Bio, LLC has at least 10 other 510(k) clearances on record.