FDA Registration
Active
🇩🇪 Germany
COLTENE/WHALEDENT GMBH & CO. KG
Reg #: 8010629
·
FEI: 3001180585
·
Expires 2026
Products
12
Proprietary Names
39
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- COLTENE/WHALEDENT GMBH & CO. KG
- Registration Number
- 8010629
- FEI Number
- 3001180585
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RAIFFEISENSTRASSE 30
- City
- LANGENAU Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K041023
Owner / Operator
- Firm Name
- COLTENE Holding AG
- Operator Number
- 9047609
- Address
- FELDWIESENSTRASSE 20, --
- City
- ALTSTAETTEN
- State
- Sankt Gallen
- Postal Code
- 9450
- Country
- CH
US Agent
- Business Name
- COLTENE/WHALEDENT INC.
- Contact Name
- Tricia Cregger
- Address
- 235 Ascot Parkway
- City
- Cuyahoga Falls
- State
- OH
- ZIP
- 44223
- Country
- US
- [email protected]
- Phone
- 330 9168904
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cotton, Roll | EFN | Class 1 | Dental | No | 1992-12-03 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 1996-10-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2005-10-20 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2025-09-15 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2008-03-07 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2019-01-21 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 1983-09-27 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2008-12-19 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 1992-12-03 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2015-06-26 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1992-12-03 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 1997-02-13 |
Proprietary Names
Luna Gold
ROEKO Solomat-N
ROEKO Lunamat
ROEKO Solomat-Click
ROEKO Roll-o-mat
ROEKO Luna
ROEKO Cotton-roll
ROEKO Parotisroll
ROEKO Cotton Pellets
ROEKO Parotimat
REOKO Comprecap
ROEKO Comprecap (anatomic)
HySolate Flexi Dam
ROEKO Gutta Flow® 2 Accessories (Mixing tips)
Alpen Steel separating strips
ROEKO Stay put non impregnated
ROEKO Retracto
CanalPro Color Syringes
Hygenic Gutta Percha Points
HyFlex Guttapercha Points
MicroMega Guttapercha Points
ROEKO Guttapercha Points
ROEKO GuttaFlow
ROEKO GuttaFlow 2
HyFlex Paper Points
Hygenic(HYG) Paper Points (PP), HYG Absorbent PP, Hygenic Spectra Points Absorbent PP, HYG Steri-I-Cell PP
MicroMega Paper Points
ROEKO Paper Points
HyFlex CM, HyFlex EDM
ROEKO Surgitip-endo
ROEKO Aspirator tips
ROEKO Surgitip-micro
ROEKO Double Adapter
ROEKO Surgitip
HANEL Shimstock Foil
HANEL Foil Dispenser
HANEL Occlusion Foil
HANEL OccluFoil+
HANEL Articulating paper
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device