FDA device listing
Lucitone Digital Print Denture System
FDA device listing 1301499576 · LEIXIR RESOURCES PRIVATE LIMITED
Key facts
| Proprietary names | Lucitone Digital Print Denture System |
|---|---|
| Owner/operator | LEIXIR RESOURCES PRIVATE LIMITED |
| Owner/operator number | 10056722 |
| Product codes | EBD, EBG, EBI, KLE, PZY |
| Device names | EBD - Coating, Filling Material, Resin, EBG - Crown And Bridge, Temporary, Resin, EBI - Resin, Denture, Relining, Repairing, Rebasing, KLE - Agent, Tooth Bonding, Resin, PZY - Additively Manufactured, Preformed, Resin Denture Tooth |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3200, 872.3310, 872.3590, 872.3760, 872.3770 |
| Review panels | Dental |
| Registered establishments | M/S LEIXIR RESOURCES PVT. LTD |
| Establishment registrations | 3014270094 |
| FEI numbers | 3014270094 |
| Establishment operations | Contract 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