Z-Systems AG: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Z-Systems AG” (first 2007, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 261 days. Since 2017 the median was 250 days, against 210 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 281 |
| 2013 | 1 | 86 |
| 2014 | 1 | 293 |
| 2015 | 1 | 206 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 239 |
| 2021 | 1 | 261 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Z-Systems AG took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 8 | 8 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Dental (8)
- General Hospital (1)
Most recent Z-Systems AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201878 | ST-Z5 | KCT | 2021-03-25 | 261 |
| K201712 | Z5-TL | DZE | 2020-12-01 | 161 |
| K200386 | Z5-BL | DZE | 2020-10-14 | 239 |
| K190243 | Z5-BL | DZE | 2020-01-03 | 331 |
| K150021 | Z5m(t) | DZE | 2015-07-31 | 206 |
| K132881 | Z5C | DZE | 2014-07-03 | 293 |
| K131701 | Z5MLB, Z5MLC | DZE | 2013-09-05 | 86 |
| K120793 | Z-LOOK3 EVO SLM | DZE | 2012-12-21 | 281 |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | DZE | 2007-10-29 | 425 |
Recalls
openFDA lists no recalls under a recalling firm named Z-Systems AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Z-Systems AG?
FDA lists 9 510(k) clearances under the applicant name “Z-Systems AG” (first 2007, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Z-Systems AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Z-Systems AG is 261 days. Since 2017: 250 days, versus 210 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Z-Systems AG?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 8); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Next steps
- See all 9 Z-Systems AG clearances with predicates and recalls
- Run predicate analysis for product code DZE, Z-Systems AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.