FDA product code MCL: Kit, Test, In Vitro Periodontal
MCL is the FDA product code for kit, test, in vitro periodontal. It is a Class III device, reviewed by the Dental panel. Devices under MCL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, In Vitro Periodontal |
| Device class | Class III |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MCL devices
openFDA lists no recalls for product code MCL.
Frequently asked questions
What is FDA product code MCL?
MCL is the FDA product code for kit, test, in vitro periodontal. It is a Class III device, reviewed by the Dental panel.
What device class is MCL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MCL
- Run a recall and safety report across every MCL manufacturer
- Watch product code MCL 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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