Z-Systems AG
Oensingen Solothurn, CH
Z-SYSTEMS AG appears in FDA device records in Oensingen Solothurn, CH. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Z-Systems AG between 2007 and 2021. The busiest year on record is 2020, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201878 | ST-Z5 | KCT | Substantially Equivalent | |
| K201712 | Z5-TL | DZE | Substantially Equivalent | |
| K200386 | Z5-BL | DZE | Substantially Equivalent | |
| K190243 | Z5-BL | DZE | Substantially Equivalent | |
| K150021 | Z5m(t) | DZE | Substantially Equivalent | |
| K132881 | Z5C | DZE | Substantially Equivalent | |
| K131701 | Z5MLB, Z5MLC | DZE | Substantially Equivalent | |
| K120793 | Z-LOOK3 EVO SLM | DZE | Substantially Equivalent | |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006948427 | 3006948427 | Z-SYSTEMS AG | Werkhofstrasse 5, Oensingen Solothurn 4702 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain