510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JAZClass II

Prosthesis, Facial, Mandibular Implant

21 CFR 874.3695 / Ear, Nose, Throat
FDA source (opens on fda.gov)

JAZ is the FDA product code for Prosthesis, Facial, Mandibular Implant, a class II device type, regulated under 21 CFR 874.3695. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JAZ
Device name
Prosthesis, Facial, Mandibular Implant
Regulation
21 CFR 874.3695
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JAZ

By decision year
2 clearances under product code JAZ with a decision year between 1982 and 1990, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JAZ by decision year
YearClearances
19821
19901

Applicants with the most clearances

Product code JAZ
Applicants holding the most 510(k) clearances under product code JAZ
ApplicantClearances
Invotec International, Inc.1
Xomed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code