510(k) K112875

BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS by Blue Sky Bio, LLC — Product Code DZE

K112875 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 27, 2012. 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.