FDA device listing
GR-16 x-ray,GR-19.1 OA,GR-19.1 OA I MSI,Imprimo LC Splint comfort,Imprimo LC Splint comfort MSI
FDA device listing 1770225837 · pro3dure medical GmbH
Key facts
| Proprietary names | GR-16 x-ray,GR-19.1 OA,GR-19.1 OA I MSI,Imprimo LC Splint comfort,Imprimo LC Splint comfort MSI |
|---|---|
| Owner/operator | pro3dure medical GmbH |
| Owner/operator number | 10059691 |
| Product codes | DYT |
| Device names | DYT - Maintainer, Space Preformed, Orthodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5525 |
| Review panels | Dental |
| Registered establishments | PRO3DURE MEDICAL GMBH |
| Establishment registrations | 3014888923 |
| FEI numbers | 3014888923 |
| Establishment operations | 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