FDA device listing
Multi-Unit Abutment Xeal Conical Connection,NobelActive TiUltra Implants,NobelParallel CC TiUltra Implants,NobelReplace…
FDA device listing 1540413833 · Nobel Biocare Services AG
Key facts
| Proprietary names | Multi-Unit Abutment Xeal Conical Connection,NobelActive TiUltra Implants,NobelParallel CC TiUltra Implants,NobelReplace CC TiUltra Implants,On1 Base Xeal |
|---|---|
| Owner/operator | Nobel Biocare Services AG |
| Owner/operator number | 8030879 |
| Premarket submissions | K202344 |
| Product codes | DZE, NHA, PNP |
| Device names | DZE - Implant, Endosseous, Root-Form, NHA - Abutment, Implant, Dental, Endosseous, PNP - Dental Abutment Design Software For Dental Laboratory |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3630, 872.3640 |
| Review panels | Dental |
| Registered establishments | NOBEL BIOCARE AB, NOBEL BIOCARE AB, PRODUKTION, NOBEL BIOCARE DISTRIBUTION CENTER BV, Nobel Biocare Services AG, NOBEL BIOCARE USA, LLC |
| Establishment registrations | 2027971, 9611992, 9611993, 3006540014, 3008693672 |
| FEI numbers | 1000125598, 3002807692, 3002807693, 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