Contract manufacturerCOLTENE/WHALEDENT INC. (Cuyahoga Falls, OH)OhioDentalClass IIClass I
COLTENE/WHALEDENT INC.
Contract manufacturer ยท Cuyahoga Falls, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2416455 (openFDA record; or search FDA's registration database)
- FEI number
- 2416455
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Coltene/Whaledent AG (FDA owner/operator no. 9089944)
- Registered address
- 235 Ascot Pkwy, Cuyahoga Falls, OH 44223
- Contract listings
- 8 device listings, 8 product codes, first listed Oct 7, 2003
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | Class II | Dental | Contract manufacturing | Feb 14, 2023 |
| EEF | Clamp, Rubber Dam | Class I | Dental | Contract manufacturing | Oct 7, 2003 |
| EJB | Handle, Instrument, Dental | Class I | Dental | Contract manufacturing | Dec 9, 2003 |
| EJE | Frame, Rubber Dam | Class I | Dental | Contract manufacturing | Oct 7, 2003 |
| EJG | Forceps, Rubber Dam Clamp | Class I | Dental | Contract manufacturing | Oct 7, 2003 |
| EJL | Bur, Dental | Class I | Dental | Contract manufacturing | May 8, 2007 |
| ELC | Scaler, Ultrasonic | Class II | Dental | Contract manufacturing | Aug 1, 2024 |
| KHR | Absorber, Saliva, Paper | Class I | Dental | Contract manufacturing | Oct 7, 2003 |