FDA device listing
650-08 Perforated Strip,650-09 Reducer Strip(Thick),650-10 Reducer Strip(Thin),650-12 Reducer Strip(One-side)
FDA device listing 1110932729 · OSSTEM ORTHODONTICS Inc.
Key facts
| Proprietary names | 650-08 Perforated Strip,650-09 Reducer Strip(Thick),650-10 Reducer Strip(Thin),650-12 Reducer Strip(One-side) |
|---|---|
| Owner/operator | OSSTEM ORTHODONTICS Inc. |
| Owner/operator number | 10050607 |
| Product codes | EHM |
| Device names | EHM - Strip, Polishing Agent |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6010 |
| Review panels | Dental |
| Registered establishments | OSSTEM ORTHODONTICS Inc. |
| Establishment registrations | 3006946041 |
| FEI numbers | 3006946041 |
| Establishment operations | 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