FDA device listing
PrimeTaper
FDA device listing 1511591906 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | PrimeTaper |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Premarket submissions | K210610 |
| Product codes | DZE |
| Device names | DZE - Implant, Endosseous, Root-Form |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3640 |
| Review panels | Dental |
| Registered establishments | Dentsply IH AB, DENTSPLY IH BV, Sirona Dental Systems GmbH, Wellspect Healthcare |
| Establishment registrations | 9612468, 9681851, 3009632672, 3011824442 |
| FEI numbers | 3002806429, 3002807009, 3009632672, 3011824442 |
| Establishment operations | Contract Sterilizer, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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