FDA device listing
CP Probe 15 (1-15mm),Explorer 17,Explorer 17-9,Explorer 17C-23,Explorer 23,Explorer 29,Explorer 2A,Explorer 33,Explorer…
FDA device listing 1768365055 · ErgoDenta ApS
Key facts
| Proprietary names | CP Probe 15 (1-15mm),Explorer 17,Explorer 17-9,Explorer 17C-23,Explorer 23,Explorer 29,Explorer 2A,Explorer 33,Explorer 3A,Explorer 5,Explorer 5-8,Explorer 5-9,Explorer 8,Explorer 9,Explorer-Holst,Furcation Probe,Nabers Probe,Nabers Probes (ball-end),Probe 11,Probe 12,Probe 12B,Probe 15,Probe 18,Probe 2,Probe 2B,Probe CP 11,Probe CP 11 (3-6-8-11mm),Probe CP 12 (3-6-9-12mm),Probe CP 12B… |
|---|---|
| Owner/operator | ErgoDenta ApS |
| Owner/operator number | 10094892 |
| Product codes | EIX |
| Device names | EIX - Probe, Periodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | ERGODENTA APS |
| Establishment registrations | 3043047788 |
| FEI numbers | 3043047788 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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