FDA product code MMU: Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
MMU is the FDA product code for adhesive, denture, acacia and karaya with sodium borate > 12% by weight. It is a Class III device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel. Devices under MMU reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight |
| Device class | Class III |
| Regulation | 21 CFR 872.3400 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for MMU devices
openFDA lists no recalls for product code MMU.
Frequently asked questions
What is FDA product code MMU?
MMU is the FDA product code for adhesive, denture, acacia and karaya with sodium borate > 12% by weight. It is a Class III device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel.
What device class is MMU?
Class III, regulation 21 CFR 872.3400. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MMU
- Run a recall and safety report across every MMU manufacturer
- Watch product code MMU 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.