FDA device listing
18-250 Prophy Cups, Snap-On,18-251 Prophy Cups, Screw-In,18-M252 Prophy Cups, RA, Metal Shank,18-P252 Prophy Cups, RA…
FDA device listing 1517745844 · Premium Plus International Limited
Key facts
| Proprietary names | 18-250 Prophy Cups, Snap-On,18-251 Prophy Cups, Screw-In,18-M252 Prophy Cups, RA, Metal Shank,18-P252 Prophy Cups, RA, Plastic Shank,Dentmas,S-251 Prophy Cups, Screw-In,S-M252 Prophy Cups, RA, Metal Shank,T-251 Prophy Cups, Screw-In,T-M252 Prophy Cups, RA, Metal Shank,T-P252 Prophy Cups, RA, Plastic Shank |
|---|---|
| Owner/operator | Premium Plus International Limited |
| Owner/operator number | 10023657 |
| Product codes | EHK |
| Device names | EHK - Cup, Prophylaxis |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6290 |
| Review panels | Dental |
| Registered establishments | Premium Plus International Limited |
| Establishment registrations | 3006847937 |
| FEI numbers | 3006847937 |
| Establishment operations | Manufacturer |
| 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