FDA device listing
Abutment Post,BellaTek Encode Healing Abutment,Certain BellaTek Encode Healing Abutment,Certain Conical Abutment,Certain…
FDA device listing 1073348797 · ZimVie US Corp LLC
Key facts
| Proprietary names | Abutment Post,BellaTek Encode Healing Abutment,Certain BellaTek Encode Healing Abutment,Certain Conical Abutment,Certain Conical Abutment Screw,Certain EP Healing Abutment,Certain GingiHue Post,Certain Gold-Tite Hexed Screw,Certain IOL Abutment,Certain Provide Abutment,Certain Standard Abutment,Certain Straight Healing Abutment,Certain Temporary Hexed Cylinder,Certain Temporary Non-Hexed… |
|---|---|
| Owner/operator | ZimVie US Corp LLC |
| Owner/operator number | 1038806 |
| Premarket submissions | K072642 |
| Product codes | NHA |
| Device names | NHA - Abutment, Implant, Dental, Endosseous |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3630 |
| 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