FDA device listing
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture
FDA device listing 1021398996 · Summit Packaging Solutions LLC
Key facts
| Proprietary names | Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture |
|---|---|
| Owner/operator | Summit Packaging Solutions LLC |
| Owner/operator number | 10051178 |
| Product codes | KOO |
| Device names | KOO - Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3490 |
| Review panels | Dental |
| Registered establishments | Summit Packaging Solutions LLC |
| Establishment registrations | 3012117640, 3012118920 |
| FEI numbers | 3012117640, 3012118920 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database