510(k) K182338

Blue Sky Bio Computerized Orthodontic Bracket System by Blue Sky Bio — Product Code DYW

K182338 is an FDA 510(k) premarket notification submitted by Blue Sky Bio for the device "Blue Sky Bio Computerized Orthodontic Bracket System". The FDA issued a decision of Substantially Equivalent on November 9, 2018. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Blue Sky Bio has at least 10 other 510(k) clearances on record.