FDA Registration
Active
🇨🇭 Switzerland
CeramTec Schweiz GmbH
Reg #: 3008388248
·
FEI: 3008388248
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CeramTec Schweiz GmbH
- Registration Number
- 3008388248
- FEI Number
- 3008388248
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bodenaeckerstrasse 5
- City
- Spreitenbach Aargau
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K152385
Owner / Operator
- Firm Name
- CeramTec Schweiz GmbH
- Operator Number
- 10032409
- Address
- Bodenaeckerstrasse 5
- City
- Spreitenbach
- State
- Aargau
- Postal Code
- 8957
- Country
- CH
- Correspondent
- Stefan Ruck
US Agent
- Business Name
- ICON Clinical Research
- Contact Name
- Jamie Harris
- Address
- 731 Arbor Way Ste 100
- City
- Blue Bell
- State
- PA
- ZIP
- 19422
- Country
- US
- [email protected]
- Phone
- 661 6459048
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2018-12-12 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2016-10-06 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2016-10-06 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2016-10-11 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2010-08-06 |
Proprietary Names
Zeramex Dental Implant System
Establishment Types
Manufacture Medical Device