FDA device listing
Diamond Paste,Enamel Pro Prophy Paste
FDA device listing 1744626959 · Premier Dental Products Company
Key facts
| Proprietary names | Diamond Paste,Enamel Pro Prophy Paste |
|---|---|
| Owner/operator | Premier Dental Products Company |
| Owner/operator number | 2511556 |
| Premarket submissions | K062166 |
| 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 | PREMIER DENTAL PRODUCTS CO. |
| Establishment registrations | 2511556 |
| FEI numbers | 2511556 |
| Establishment operations | 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