Z-Systems
Also known as: Z-SYSTEMS AG, Z-Systems AG
A Swiss manufacturer of metal-free zirconia ceramic dental implants, a pioneer of the ceramic implant since 2004.
Key facts
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance8 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K201712 | Z5-TL | Z-Systems AG | 2020-12-01 |
| K200386 | Z5-BL | Z-Systems AG | 2020-10-14 |
| K190243 | Z5-BL | Z-Systems AG | 2020-01-03 |
| K150021 | Z5m(t) | Z-Systems AG | 2015-07-31 |
| K132881 | Z5C | Z-Systems AG | 2014-07-03 |
| K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013-09-05 |
| K120793 | Z-LOOK3 EVO SLM | Z-Systems AG | 2012-12-21 |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Z-Systems AG | 2007-10-29 |
Clearance records for Z-Systems were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Z-Systems.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Z-SYSTEMS — Pioneering ceramic dental implants — Z-Systems AG. Accessed 2026-07-22.