FDA device listing
Basic retainer,Bleaching retainer,Ecodont retainer,Finishing retainer,Fixed Retainer,Smartfix retainer
FDA device listing 1816872863 · MODERN DENTAL LABORATORY CO.LTD.
Key facts
| Proprietary names | Basic retainer,Bleaching retainer,Ecodont retainer,Finishing retainer,Fixed Retainer,Smartfix retainer |
|---|---|
| Owner/operator | MODERN DENTAL LABORATORY CO.LTD. |
| Owner/operator number | 9059261 |
| 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 | Aceso Dental Laboratory Company Limited, Modern Dental Global Solutions Limited, Modern Dental International Trading Limited, Modern Dental Laboratory (DG) Co., Ltd. |
| Establishment registrations | 3010022489, 3013950969, 3015674959, 3019793783 |
| FEI numbers | 3010022489, 3013950969, 3015674959, 3019793783 |
| Establishment operations | Foreign Exporter, 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