FDA device listing
Caulk Post & Core Kit,Paper Points
FDA device listing 1028423531 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | Caulk Post & Core Kit,Paper Points |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Product codes | EKN |
| Device names | EKN - Point, Paper, Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3830 |
| Review panels | Dental |
| Registered establishments | DENTSPLY DENTAL (TIANJIN) CO., LTD., DENTSPLY IH BV, DENTSPLY INDUSTRIA E COMERCIO LTDA, DENTSPLY NORTH AMERICA LLC, MAILLEFER INSTRUMENTS HOLDING SARL, TULSA DENTAL PRODUCTS LLC |
| Establishment registrations | 2320721, 8031010, 8040288, 3000303964, 3006186796, 3011824442 |
| FEI numbers | 1000185904, 1000554802, 3000303964, 3002806793, 3006186796, 3011824442 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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