FDA device listing
Positioner, Tooth, Preformed
FDA device listing 1319271484 · Huizhou Gold Rose Technology Co.,Ltd
Key facts
| Owner/operator | Huizhou Gold Rose Technology Co.,Ltd |
|---|---|
| Owner/operator number | 10078391 |
| Product codes | KMY |
| Device names | KMY - Positioner, Tooth, Preformed |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5525 |
| Review panels | Dental |
| Registered establishments | HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD |
| Establishment registrations | 3017618900 |
| FEI numbers | 3017618900 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Foreign Private Label Distributor, 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