FDA device listing
Archwire Markers,BRACKET PLACEMENT/POSITIONER,Carriere SLX 3D EZ Twist Opener Tweezer,Carriere SLX CFI Opening…
FDA device listing 1264188943 · ORTHO ORGANIZERS, INC.
Key facts
| Proprietary names | Archwire Markers,BRACKET PLACEMENT/POSITIONER,Carriere SLX 3D EZ Twist Opener Tweezer,Carriere SLX CFI Opening Tool,Elastic Attacher,Elastic Directors,Elastic Remover,Explorer,Falcon Instruments,Lotus Plus® DS SLB Turn Key,ORTHODONTIC INSTRUMENTS,SLB Opening Tool,X7 Instruments |
|---|---|
| Owner/operator | ORTHO ORGANIZERS , INC. |
| Owner/operator number | 2081322 |
| Product codes | DZN |
| Device names | DZN - Instruments, Dental Hand |
| 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