FDA device listing
K-Spray Handpiece Spray,STATCARE Handpiece Spray,STATMATIC Spray
FDA device listing 1525692673 · Coltene/Whaledent AG
Key facts
| Proprietary names | K-Spray Handpiece Spray,STATCARE Handpiece Spray,STATMATIC Spray |
|---|---|
| Owner/operator | Coltene/Whaledent AG |
| Owner/operator number | 9089944 |
| Premarket submissions | K062418 |
| Product codes | EFB |
| Device names | EFB - Handpiece, Air-Powered, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | SCICAN LTD. |
| Establishment registrations | 8043629 |
| FEI numbers | 1000273801 |
| Establishment operations | Foreign Exporter, Foreign Private Label Distributor |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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