Cleared Traditional

3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP

K141027 · Implantech Associates, Inc. · General & Plastic Surgery

Jul 2014

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K141027 is an FDA 510(k) clearance for the 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on July 10, 2014, 79 days after receiving the submission on April 22, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number	K141027 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2014
Decision Date	July 10, 2014
Days to Decision	79 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF