FDA device listing
Biodentine
FDA device listing 1595216392 · Novocol Pharmaceutical of Canada, Inc.
Key facts
| Proprietary names | Biodentine |
|---|---|
| Owner/operator | Novocol Pharmaceutical of Canada, Inc. |
| Owner/operator number | 10048017 |
| Premarket submissions | K140132 |
| Product codes | EMA, KIF |
| Device names | EMA - Cement, Dental, KIF - Resin, Root Canal Filling |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3275, 872.3820 |
| Review panels | Dental |
| Registered establishments | NOVOCOL PHARMACEUTICAL OF CANADA, INC. |
| Establishment registrations | 3002807757 |
| FEI numbers | 3002807757 |
| Establishment operations | Foreign Exporter, Foreign Private Label Distributor |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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