FDA device listing
FASTBRACES® CLASSIC™ Metal LL3,FASTBRACES® CLASSIC™ Metal LL/LR 1/2,FASTBRACES® CLASSIC™ Metal LL/UR 6,FASTBRACES®…
FDA device listing 1270200354 · Orthoworld, L.L.C.
Key facts
| Proprietary names | FASTBRACES® CLASSIC™ Metal LL3,FASTBRACES® CLASSIC™ Metal LL/LR 1/2,FASTBRACES® CLASSIC™ Metal LL/UR 6,FASTBRACES® CLASSIC™ Metal LR3,FASTBRACES® CLASSIC™ Metal UL1,FASTBRACES® CLASSIC™ Metal UL2,FASTBRACES® CLASSIC™ Metal UL3,FASTBRACES® CLASSIC™ Metal U/L 4/5,FASTBRACES® CLASSIC™ Metal UL/LR 6,FASTBRACES® CLASSIC™ Metal UR1,FASTBRACES® CLASSIC™ Metal UR2,FASTBRACES® CLASSIC™ Metal… |
|---|---|
| Owner/operator | Orthoworld, L.L.C. |
| Owner/operator number | 10038866 |
| Product codes | EJF |
| Device names | EJF - Bracket, Metal, Orthodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5410 |
| Review panels | Dental |
| Registered establishments | ORTHOWORLD, L.L.C. |
| Establishment registrations | 3009402818 |
| FEI numbers | 3009402818 |
| Establishment operations | 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