FDA device listing
MAXMIN Prophylaxis Paste,NADA Pumice Paste,NEXT Prophylaxis Paste
FDA device listing 1833816397 · PREVENTIVE TECHNOLOGIES, INC.
Key facts
| Proprietary names | MAXMIN Prophylaxis Paste,NADA Pumice Paste,NEXT Prophylaxis Paste |
|---|---|
| Owner/operator | PREVENTIVE TECHNOLOGIES, INC. |
| Owner/operator number | 9020368 |
| Premarket submissions | K100539 |
| Product codes | EJR |
| Device names | EJR - Agent, Polishing, Abrasive, Oral Cavity |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6030 |
| Review panels | Dental |
| Registered establishments | PREVENTIVE TECHNOLOGIES, INC. |
| Establishment registrations | 1061053 |
| FEI numbers | 1000511545 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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