FDA product code KON: Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
KON is the FDA product code for adhesive, denture, polyacrylamide polymer (modified cationic). It is a Class III device, regulated under 21 CFR 872.3480 and reviewed by the Dental panel. Devices under KON reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 per 61 FR 50707 on 9/26/96
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) |
| Device class | Class III |
| Regulation | 21 CFR 872.3480 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for KON devices
openFDA lists no recalls for product code KON.
Frequently asked questions
What is FDA product code KON?
KON is the FDA product code for adhesive, denture, polyacrylamide polymer (modified cationic). It is a Class III device, regulated under 21 CFR 872.3480 and reviewed by the Dental panel.
What device class is KON?
Class III, regulation 21 CFR 872.3480. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KON
- Run a recall and safety report across every KON manufacturer
- Watch product code KON 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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