FDA product code JAZ: Prosthesis, Facial, Mandibular Implant
JAZ is the FDA product code for prosthesis, facial, mandibular implant. It is a Class II device, regulated under 21 CFR 874.3695 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under JAZ, from 2 different applicants. The average 510(k) review took 106 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Facial, Mandibular Implant |
| Device class | Class II |
| Regulation | 21 CFR 874.3695 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every JAZ clearance
Top JAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invotec International, Inc. | 1 | 1990-10-31 |
| Xomed, Inc. | 1 | 1982-07-26 |
Most recent JAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901923 | Invotec International, Inc. | INVOTEC POLY-MESH MANDIBULAR TRAY | 1990-10-31 | 184 |
| K821904 | Xomed, Inc. | XOMED MANDIBULAR TRAY | 1982-07-26 | 28 |
Recalls for JAZ devices
openFDA lists no recalls for product code JAZ.
Frequently asked questions
What is FDA product code JAZ?
JAZ is the FDA product code for prosthesis, facial, mandibular implant. It is a Class II device, regulated under 21 CFR 874.3695 and reviewed by the Ear, Nose and Throat panel.
What device class is JAZ?
Class II, regulation 21 CFR 874.3695. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAZ?
Across 2 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most JAZ clearances?
Invotec International, Inc. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JAZ
- Run a recall and safety report across every JAZ manufacturer
- Watch product code JAZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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