FDA Registration
Inactive
🇩🇪 Germany
PREFIT10 3IC 4.1
·
Expires 2025
Products
1
Proprietary Names
33
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
- K222368
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
PREFIT10 3IC 4.1
PREFIT14 TSV 3.5
PREFIT14 3IC 4.1
PREFIT10 TSV 5.7
SCREW NBA 3.5
PREFIT14 TSV 5.7
PREFIT10 3IC 5
PREFIT14 TSV 4.5
PREFIT14 NBR 3.5
PREFIT10 TSV 4.5
SCREW NBR 3.5
PREFIT14 NBR 5
PREFIT10 NBA 4.3/5
PREFIT14 NBA 3.5
PREFIT10 3IC 6
SCREW NBA 4.3/5
PREFIT10 NBA 5.5
PREFIT10 TSV 3.5
PREFIT14 NBR 4.3
PREFIT14 3IC 6
PREFIT14 3IC 5
PREFIT14 NBA 5.5
PREFIT14 NBA 4.3/5
PREFIT10 NBA 3.5
PREFIT10 NBR 3.5
PREFIT10 NBR 5
SCREW 3IC 3.4/4.1/5/6
SCREW TSV 3.5/4.5/5.7
PREFIT10 3IC 3.4
PREFIT10 NBR 6
SCREW NBR 4.3/5/6
PREFIT10 NBR 4.3
PREFIT14 NBR 6
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)