Establishment registration
COLTENE/WHALEDENT INC.
FDA establishment registration 2416455 · CUYAHOGA FALLS, US
Key facts
| Registration number | 2416455 |
|---|---|
| Establishment name | COLTENE/WHALEDENT INC. |
| Owner/operator | Coltene/Whaledent AG |
| Owner/operator number | 9089944 |
| FEI number | 2416455 |
| Address | 235 Ascot Pkwy |
| City | CUYAHOGA FALLS |
| State | OH |
| Country | US |
| Establishment types | Export-only manufacturer |
| Registration valid through | 2026 |
| Product codes listed | DZA, DZM, DZN, DZP, EAT, EBL, EBZ, EEF, EGD, EHM, EHY, EIC, EIE, EJB, EJE, EJG, EJL, EJQ, EJR, EKQ, EKS, EKX, EKZ, ELC, ELR, FLG, KHR, KIF, KJJ, KMH and 4 more |
| Device classes | 1, 2, U |
At a glance
- 10–99 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database