FDA device listing
Procera Abutments Branemark System Zirconia,Procera Abutments NobelReplace Zirconia
FDA device listing 2019631948 · Nobel Biocare Services AG
Key facts
| Proprietary names | Procera Abutments Branemark System Zirconia,Procera Abutments NobelReplace Zirconia |
|---|---|
| Owner/operator | Nobel Biocare Services AG |
| Owner/operator number | 8030879 |
| Premarket submissions | K031719 |
| 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 | NOBEL BIOCARE AB, NOBEL BIOCARE AB, PRODUKTION, NOBEL BIOCARE DISTRIBUTION CENTER BV, NOBEL BIOCARE PROCERA, LLC, Nobel Biocare Services AG, NOBEL BIOCARE USA, LLC |
| Establishment registrations | 2027971, 9611992, 9611993, 3005031178, 3006540014, 3008693672 |
| FEI numbers | 1000125598, 3002807692, 3002807693, 3005031178, 3006540014, 3008693672 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Contract Manufacturer, Specification Developer |
| 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