FDA device listing
1st Generation Surgical Templates, NobelGuide,2nd Generation Surgical Templates, NobelGuide,Abutment Release…
FDA device listing 1342295174 · Nobel Biocare Services AG
Key facts
| Proprietary names | 1st Generation Surgical Templates, NobelGuide,2nd Generation Surgical Templates, NobelGuide,Abutment Release Pin,Abutment Replica Multi-unit,Abutment Replica Snappy,Abutment Retrieval Tools/Instruments Titanium,Abutment Retrieval Tools/Instruments Zirconia,Abutment Screw Remover,Abutment Screw Retrieval Instrument,Abutment Screw Retrieval Reverse Drill,Adapter for Manual Torque Wrench… |
|---|---|
| Owner/operator | Nobel Biocare Services AG |
| Owner/operator number | 8030879 |
| 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 | 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, Contract Manufacturer, Foreign Exporter, 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