FDA device listing
DTX Studio Lab
FDA device listing 1744993311 · PaloDEx Group Oy
Key facts
| Proprietary names | DTX Studio Lab |
|---|---|
| Owner/operator | PaloDEx Group Oy |
| Owner/operator number | 9079085 |
| Premarket submissions | K181932 |
| Product codes | NHA, PNP |
| Device names | NHA - Abutment, Implant, Dental, Endosseous, PNP - Dental Abutment Design Software For Dental Laboratory |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3630 |
| Review panels | Dental |
| Registered establishments | PALODEX GROUP OY |
| Establishment registrations | 3005383085 |
| FEI numbers | 3005383085 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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