510(k) K153064

Blue Sky Bio Zygomatic Implant System by Blue Sky Bio, LLC — Product Code DZE

K153064 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "Blue Sky Bio Zygomatic Implant System". The FDA issued a decision of Substantially Equivalent on April 29, 2016. 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.