Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Implant, Malar (LZK) (1) Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (KKY) (1) Plate, Fixation, Bone (HRS) (1) Prosthesis, Chin, Internal (FWP) (1) Prosthesis, Nose, Internal (FZE) (1)