FDA Registration
Inactive
🇩🇪 Germany
SCREW KEP 3.5/4.1/5
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SCHWEIZER FEINWERKTECHNIK GMBH
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Reuteweg 4
- City
- Bad Boll Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K182246
Owner / Operator
- Firm Name
- Schweizer Feinwerktechnik GmbH
- Operator Number
- 10093456
- Address
- Reuteweg 4
- City
- Bad Boll
- State
- Baden-Wurttemberg
- Postal Code
- 73087
- Country
- DE
- Correspondent
- Mirjam Edelmann
US Agent
- Business Name
- Medagent Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-06-17 |
Proprietary Names
SCREW KEP 3.5/4.1/5
PREFIT10 KEP 4.1
PREFIT14 KEP 4.1
PREFIT14 KEP 5
PREFIT10 KEP 3.5
PREFIT10 KEP 5
PREFIT14 KEX 6.5
PREFIT14 KEX 5
PREFIT10 KEX 5
PREFIT10 KEX 6.5
PREFIT14 KEP 3.5
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)