FDA device listing
Denture Preformed (Partially Prefabricated Denture)
FDA device listing 1640346787 · Integrity Dental Services LLC
Key facts
| Proprietary names | Denture Preformed (Partially Prefabricated Denture) |
|---|---|
| Owner/operator | Integrity Dental Services LLC |
| Owner/operator number | 10089801 |
| Product codes | EKO |
| Device names | EKO - Denture Preformed (Partially Prefabricated Denture) |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3600 |
| Review panels | Dental |
| Registered establishments | INTEGRITY DENTAL SERVICES LLC |
| Establishment registrations | 3023082366 |
| FEI numbers | 3023082366 |
| 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