FDA device listing
Prime-Dent Chemical Cure Composite Restorative Material,Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive
FDA device listing 1907544956 · PRIME DENTAL MANUFACTURING, INC.
Key facts
| Proprietary names | Prime-Dent Chemical Cure Composite Restorative Material,Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive |
|---|---|
| Owner/operator | PRIME DENTAL MANUFACTURING, INC. |
| Owner/operator number | 9039081 |
| Premarket submissions | K994224 |
| Product codes | EBF, KLE |
| Device names | EBF - Material, Tooth Shade, Resin, KLE - Agent, Tooth Bonding, Resin |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3200, 872.3690 |
| Review panels | Dental |
| Registered establishments | PRIME DENTAL MANUFACTURING, INC. |
| Establishment registrations | 1424442 |
| FEI numbers | 3002811563 |
| Establishment operations | Manufacturer |
| 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