510(k) K141027

3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP by Implantech Associates, Inc. — Product Code FWP

K141027 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP". The FDA issued a decision of Substantially Equivalent on July 10, 2014. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.