510(k) K021833

MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM by Blue Sky Bio — Product Code DZE

K021833 is an FDA 510(k) premarket notification submitted by Blue Sky Bio for the device "MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 10, 2002. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Blue Sky Bio has at least 10 other 510(k) clearances on record.