FDA Registration
Active
🇨🇭 Switzerland
Z-SYSTEMS AG
Reg #: 3006948427
·
FEI: 3006948427
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Z-SYSTEMS AG
- Registration Number
- 3006948427
- FEI Number
- 3006948427
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Werkhofstrasse 5
- City
- Oensingen Solothurn
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K150021
Owner / Operator
- Firm Name
- Z-SYSTEMS AG
- Operator Number
- 10024995
- Address
- Werkhofstr. 5
- City
- Oensingen
- State
- Solothurn
- Postal Code
- 4702
- Country
- CH
US Agent
- Business Name
- PAXMED INTERNATIONAL, LLC
- Contact Name
- Floyd Larson
- Address
- 1925 Palomar Oaks Way Ste 210
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
- [email protected]
- Phone
- 858 7921235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-08-04 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-01-28 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-11-04 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-03-29 |
Proprietary Names
Z5m(t)
Z5m(t)-neo
Dental Implant Accessories
Z5-BL
Z5m
ST-Z5
Z5m lblc
Z5-TL
Z5c
Establishment Types
Manufacture Medical Device