FDA device listing
Cover Screw Headless,Cover Screw Implant,Full OSSEOTITE Implant,Full OSSEOTITE Tapered Implant,Full OSSEOTITE XP…
FDA device listing 1094667358 · ZimVie US Corp LLC
Key facts
| Proprietary names | Cover Screw Headless,Cover Screw Implant,Full OSSEOTITE Implant,Full OSSEOTITE Tapered Implant,Full OSSEOTITE XP Miniplant,Implant Cover Screw,LTX Implant,LTX XP Miniplant,NanoTite Implant,NanoTite Tapered Implant,OSSEOTITE Implant,OSSEOTITE Tapered Implant,OSSEOTITE XP Implant,OSSEOTITE XP Miniplant |
|---|---|
| Owner/operator | ZimVie US Corp LLC |
| Owner/operator number | 1038806 |
| Premarket submissions | K063286 |
| 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 | ZimVie Canada Inc., ZimVie Spain S.L.U., ZimVie US Corp LLC |
| Establishment registrations | 1038806, 1000244346, 3006411780, 3009840806 |
| FEI numbers | 1038806, 1000244346, 3006411780, 3009840806 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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