FDA device listing
EW-CC CleanCurl Curved toothbrush in blister,EW-GUMP24 Pro Gums Toothbrush BULK, 24 pcs in inner box,EW-GUMP Pro Gums…
FDA device listing 1211406007 · SCANDERRA GMBH
Key facts
| Proprietary names | EW-CC CleanCurl Curved toothbrush in blister,EW-GUMP24 Pro Gums Toothbrush BULK, 24 pcs in inner box,EW-GUMP Pro Gums Toothbrush,EW-ID7.25 L 0.8mm in bag BULK,EW-ID7.25 M 0.7mm in bag BULK,EW-ID7.25 S 0.6mm in bag BULK,EW-ID7.25 SS 0.5mm in bag BULK,EW-ID7.25 SSS 0.45mm in bag BULK,EW-ID7.25 XS 0.4mm in bag BULK,EW-ID7.40 Interdental Brush assorted SampleCube box,EW-ID7-A Interdental Brush… |
|---|---|
| Owner/operator | SCANDERRA GMBH |
| Owner/operator number | 10060196 |
| Product codes | EFW |
| Device names | EFW - Toothbrush, Manual |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6855 |
| Review panels | Dental |
| Registered establishments | SCANDERRA LLB AG |
| Establishment registrations | 3009488700 |
| FEI numbers | 3009488700 |
| Establishment operations | 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