FDA device listing
Nobel Replace, Nobel Active, Nobel Direct, Branemark System
FDA device listing 1637691426 · Elos Medtech Pinol A/S
Key facts
| Proprietary names | Nobel Replace, Nobel Active, Nobel Direct, Branemark System |
|---|---|
| Owner/operator | Elos Medtech Pinol A/S |
| Owner/operator number | 10029200 |
| Product codes | DZI |
| Device names | DZI - Drill, Bone, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.4120 |
| Review panels | Dental |
| Registered establishments | ELOS MEDTECH PINOL A/S |
| Establishment registrations | 3007689689 |
| FEI numbers | 3007689689 |
| Establishment operations | Contract Manufacturer |
| 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