Manufacturer registered with FDA
Z-Systems AG
Oensingen, Switzerland. Lists 3 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 11
- 510(k) clearances
- 82007–2020
- Markets registered in
- 1United States
- Establishments
- 1Switzerland
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Z-Systems AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Z5-BLZ5-TLZ5cZ5mZ5m lblcZ5m(t)Z5m(t)-neo | 2012 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Z5-BLZ5-TLZ5c | 2014 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Accessories | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Z-Systems AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Dec 2020 | K201712 | Z5-TL | DZE Root-Form Endosseous Implant |
| 14 Oct 2020 | K200386 | Z5-BL | DZE Root-Form Endosseous Implant |
| 3 Jan 2020 | K190243 | Z5-BL | DZE Root-Form Endosseous Implant |
| 31 Jul 2015 | K150021 | Z5m(t) | DZE Root-Form Endosseous Implant |
| 3 Jul 2014 | K132881 | Z5C | DZE Root-Form Endosseous Implant |
| 5 Sep 2013 | K131701 | Z5MLB, Z5MLC | DZE Root-Form Endosseous Implant |
| 21 Dec 2012 | K120793 | Z-LOOK3 EVO SLM | DZE Root-Form Endosseous Implant |
| 29 Oct 2007 | K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Z-SYSTEMS AGFDA reg. 3006948427 | Oensingen Solothurn, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024995). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.