FDA device listing
Cast Resin (Cast, Cast-Wax),Model Resin (DB Flex, DB Impact, DC, DT Dark, DT Dark Meharry 2.0, DT Dark Pink, DT Light…
FDA device listing 1069795698 · Suzhou laixin 3D Technology Co.,Ltd
Key facts
| Proprietary names | Cast Resin (Cast, Cast-Wax),Model Resin (DB Flex, DB Impact, DC, DT Dark, DT Dark Meharry 2.0, DT Dark Pink, DT Light, DT Light Pink),Model Resin (DT Light Pink 2.0, DT, DT Pink 2.0, DT Pink, DT Clear Pink, Dental Teeth, Dental Teeth Plus, FlexiDenture),Model Resin (FlexiDenture Pink, FlexiDenture Dark Pink, IBT, Print Teeth, Record model, Soft , Soft Pink, TempraTeeth),Model Resin (Model DM 2.0… |
|---|---|
| Owner/operator | Suzhou laixin 3D Technology Co.,Ltd |
| Owner/operator number | 10087931 |
| Product codes | EBH |
| Device names | EBH - Material, Impression Tray, Resin |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3670 |
| Review panels | Dental |
| Registered establishments | SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTD |
| Establishment registrations | 3027508795 |
| FEI numbers | 3027508795 |
| 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