FDA Registration
Active
🇺🇸 United States
TMS Link® Minuta
Reg #: 2416455
·
FEI: 2416455
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COLTENE/WHALEDENT INC.
- Registration Number
- 2416455
- FEI Number
- 2416455
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 235 Ascot Pkwy
- City
- CUYAHOGA FALLS
- State
- OH
- ZIP
- 44223
- Country
- US
Owner / Operator
- Firm Name
- Coltene/Whaledent AG
- Operator Number
- 9089944
- Address
- Altstaetten, Feldwiesenstrasse 20
- City
- Altstaetten
- State
- Sankt Gallen
- Postal Code
- CH 9450
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 1996-09-30 |
Proprietary Names
TMS Link® Minuta
TMS Link® Minikin
Max® Restorative Pins
Unity® Restorative Pins
TMS Link Plus® Minim
Bondent® Dentin Bonding Pins
TMS® Minuta
TMS Link® Minim
TMS® Minikin
TMS Link Plus® Regular
TMS® Regular
TMS Link Plus®
TMS Link® Regular
TMS® Minim
Establishment Types
Manufacture Medical Device