FDA device listing
BAND REMOVER,BRACKET PLACEMENT/POSITIONER,BRACKET REMOVER,Carriere Double Ended Opener Tool,Carriere Motion…
FDA device listing 1524196162 · ORTHO ORGANIZERS, INC.
Key facts
| Proprietary names | BAND REMOVER,BRACKET PLACEMENT/POSITIONER,BRACKET REMOVER,Carriere Double Ended Opener Tool,Carriere Motion Placer,Choice Orthodontic Instruments,Distal Bender,ENDURA PLUS,Ligature Hemostat,ORTHODONTIC INSTRUMENTS,PLASTIC NIPPERS,TRIUMPH INSTRUMENTS,TruEase locking tool,Twin Force Tool,Wire Cutter, Bracket Remover-Multip |
|---|---|
| Owner/operator | ORTHO ORGANIZERS , INC. |
| Owner/operator number | 2081322 |
| Product codes | JEX |
| Device names | JEX - Plier, Orthodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | ORTHO ORGANIZERS, INC. |
| Establishment registrations | 2081322 |
| FEI numbers | 2081322 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| 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