FDA product code LMW: Solution, Removal, Carries
LMW is the FDA product code for solution, removal, carries. It is a Class III device, reviewed by the Dental panel. Devices under LMW reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Removal, Carries |
| Device class | Class III |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LMW devices
openFDA lists no recalls for product code LMW.
Frequently asked questions
What is FDA product code LMW?
LMW is the FDA product code for solution, removal, carries. It is a Class III device, reviewed by the Dental panel.
What device class is LMW?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LMW
- Run a recall and safety report across every LMW manufacturer
- Watch product code LMW 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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