FDA device listing
BWS Band
FDA device listing 1204279160 · MYOFUNCTIONAL RESEARCH CO USA INC
Key facts
| Proprietary names | BWS Band |
|---|---|
| Owner/operator | MYOFUNCTIONAL RESEARCH CO USA INC |
| Owner/operator number | 9002061 |
| Product codes | ECM |
| Device names | ECM - Band, Preformed, Orthodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5410 |
| Review panels | Dental |
| Registered establishments | MYOFUNCTIONAL RESEARCH CORP. PTY. LTD., MYOFUNCTIONAL RESEARCH CO. USA |
| Establishment registrations | 3005505603, 3006707038 |
| FEI numbers | 3005505603, 3006707038 |
| Establishment operations | Foreign Exporter, Repackager/Relabeler |
| 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