JAZ — Prosthesis, Facial, Mandibular Implant Class II

FDA Device Classification

FDA product code JAZ covers "Prosthesis, Facial, Mandibular Implant", a Class II medical device regulated under 21 CFR 874.3695. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JAZ
Device Class
Class II
Regulation Number
874.3695
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K901923invotec internationalINVOTEC POLY-MESH MANDIBULAR TRAYOctober 31, 1990
K821904xomedXOMED MANDIBULAR TRAYJuly 26, 1982