FDA product code NBE: Sealant, Polymerizing
NBE is the FDA product code for sealant, polymerizing. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under NBE reach the market by PMA; FDA lists no cleared 510(k)s for it. 7 PMA applications cite this product code. FDA has posted 11 recalls for NBE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sealant, Polymerizing |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NBE devices
11 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-06.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code NBE?
NBE is the FDA product code for sealant, polymerizing. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is NBE?
Class III. Typical premarket route: PMA.
Have NBE devices been recalled?
Yes: 11 product recalls across 6 recall events; the most recent began 2023-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NBE
- Run a recall and safety report across every NBE manufacturer
- Watch product code NBE 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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