FDA device listing
Maintainer, Space Preformed, Orthodontic
FDA device listing 1838150600 · ORTHODENTALUSA CORP.
Key facts
| Owner/operator | ORTHODENTALUSA CORP. |
|---|---|
| Owner/operator number | 10031414 |
| 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 | ORTHODENTALUSA CORP. |
| Establishment registrations | 3007962015 |
| FEI numbers | 3007962015 |
| Establishment operations | 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