FDA device listing
Hygenic® Dental Dam Kits,Hygenic® Elasti-Dam,Hygenic® Fiesta® Dental Dam,Hygenic® Flexi Dam
FDA device listing 1651744443 · Coltene/Whaledent AG
Key facts
| Proprietary names | Hygenic® Dental Dam Kits,Hygenic® Elasti-Dam,Hygenic® Fiesta® Dental Dam,Hygenic® Flexi Dam |
|---|---|
| Owner/operator | Coltene/Whaledent AG |
| Owner/operator number | 9089944 |
| Product codes | EIE |
| Device names | EIE - Dam, Rubber |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6300 |
| Review panels | Dental |
| Registered establishments | COLTENE/WHALEDENT INC. |
| Establishment registrations | 2416455 |
| FEI numbers | 2416455 |
| 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