FDA device listing
Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl
FDA device listing 2014178774 · ZimVie US Corp LLC
Key facts
| Proprietary names | Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl |
|---|---|
| Owner/operator | ZimVie US Corp LLC |
| Owner/operator number | 1038806 |
| Product codes | NDP |
| Device names | NDP - Accessories, Implant, Dental, Endosseous |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | Zfx GmbH, ZimVie Canada Inc., ZimVie Spain S.L.U., ZimVie US Corp LLC |
| Establishment registrations | 1038806, 1000244346, 3006411780, 3008932779 |
| FEI numbers | 1038806, 1000244346, 3006411780, 3008932779 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter, 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