FDA device listing
Instrument, Ligature Tucking, Orthodontic,Instrument, Ligature Tucking, Orthodontic (All types of orthodontic…
FDA device listing 2033558827 · Hangzhou Westlake Biomaterial Co., Ltd.
Key facts
| Proprietary names | Instrument, Ligature Tucking, Orthodontic,Instrument, Ligature Tucking, Orthodontic (All types of orthodontic Instruments),XIHUBIOM |
|---|---|
| Owner/operator | Hangzhou Westlake Biomaterial Co., Ltd. |
| Owner/operator number | 10045941 |
| Product codes | ECP |
| Device names | ECP - Instrument, Ligature Tucking, Orthodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | HANGZHOU WESTLAKE BIOMATERIAL CO., LTD. |
| Establishment registrations | 3010669020 |
| FEI numbers | 3010669020 |
| Establishment operations | Contract Manufacturer, 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