FDA product code MPL: Mandibular Condyle Prosthesis
MPL is the FDA product code for mandibular condyle prosthesis. It is a Class III device, regulated under 21 CFR 872.3960 and reviewed by the Dental panel. Devices under MPL reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for MPL devices.
Definition
PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98))
Classification
| Field | Value |
|---|---|
| Device name | Mandibular Condyle Prosthesis |
| Device class | Class III |
| Regulation | 21 CFR 872.3960 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MPL devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-07.
Frequently asked questions
What is FDA product code MPL?
MPL is the FDA product code for mandibular condyle prosthesis. It is a Class III device, regulated under 21 CFR 872.3960 and reviewed by the Dental panel.
What device class is MPL?
Class III, regulation 21 CFR 872.3960. Typical premarket route: PMA.
Have MPL devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2010-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MPL
- Run a recall and safety report across every MPL manufacturer
- Watch product code MPL 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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