FDA product code KXY: Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
KXY is the FDA product code for polyvinyl methylether maleic anhydride &/or acid copolymer & carboxymethylce. It is a Class III device, regulated under 21 CFR 872.3500 and reviewed by the Dental panel. Devices under KXY 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 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce |
| Device class | Class III |
| Regulation | 21 CFR 872.3500 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for KXY devices
openFDA lists no recalls for product code KXY.
Frequently asked questions
What is FDA product code KXY?
KXY is the FDA product code for polyvinyl methylether maleic anhydride &/or acid copolymer & carboxymethylce. It is a Class III device, regulated under 21 CFR 872.3500 and reviewed by the Dental panel.
What device class is KXY?
Class III, regulation 21 CFR 872.3500. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KXY
- Run a recall and safety report across every KXY manufacturer
- Watch product code KXY 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times