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Sign in to claim this brandZ-Systems AG
US
Last updated May 27, 2026
What Z-Systems AG makes
Z-Systems AG manufactures screw endosteal dental implants, including both one-piece and two-piece designs, as well as preformed permanent suprastructures for dental prosthetics. Their portfolio also includes reusable instrument trays and dental/maxillofacial surgical procedure kits, alongside dental prosthesis/implant abutment screws. Additional offerings comprise custom dental inlays and abutment components for implant-supported restorations.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. These products are intended for use in the United States, where Z-Systems AG is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Z-Systems AG manufacture?
Z-Systems AG specializes in dental implantology and related restorative solutions. Their primary products include screw endosteal dental implants, available in both one-piece and two-piece designs, which are inserted into the jawbone to support dental prosthetics. They also produce preformed permanent suprastructures for these implants, reusable instrument trays for surgical procedures, and dental/maxillofacial surgical kits. Additionally, the company offers dental prosthesis/implant abutment screws and custom dental inlays, all designed to facilitate implant-supported restorations.
Where is Z-Systems AG based, and where are their devices intended for use?
Z-Systems AG is headquartered in the United States. Their devices are specifically intended for use within the U.S. regulatory environment, where they are classified and listed under applicable FDA pathways.
Which regulatory registries or pathways are Z-Systems AG’s devices listed under?
Z-Systems AG’s devices are classified as Class II under FDA regulations. Their products are listed via the 510(k) premarket notification pathway and the Unique Device Identifier (UDI) system, which are standard regulatory processes for ensuring compliance and traceability of medical devices in the U.S.
How are Z-Systems AG’s dental implant devices classified under FDA regulations?
All of Z-Systems AG’s dental implant-related devices fall under the FDA’s Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as dental implants, which require precise placement and long-term stability in the jawbone.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zsystems.com
- —
- —
- [email protected]
- Phone
- (877) 874 9407
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 483189556
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Z5m | Z5m-50-08 | FDA UDI | Class II | Active |
| Z5m | Z5m-50-12 | EUDAMEDFDA UDI | Class II | Active |
| Z5_m_c_mt Inlay | Z5_m_c_mt Inlay | EUDAMEDFDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-4008 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-40-08 | FDA UDI | Class II | Unknown |
| Z5-Bl | Z5-BL-3608 | FDA UDI | Class II | Active |
| Z5c | Z5c-A15s | FDA UDI | Class II | Active |
| Z5-BL_TL-leer | Z5-BL_TL-leer | EUDAMEDFDA UDI | Class II | Active |
| Z5m | Z5m-40-08 | EUDAMEDFDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-4008 | EUDAMEDFDA UDI | Class II | Active |
| Z5m(t) | Z5m(t)-40-08 | FDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-4010 | EUDAMEDFDA UDI | Class II | Active |
| Z5m(t) | Z5m(t)-40-12 | FDA UDI | Class II | Active |
| Z5m | Z5m-40-10 | FDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-5008 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-A00s | FDA UDI | Class II | Active |
| Z5m | Z5m-40-12 | FDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-3610 | EUDAMEDFDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-5008 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-50-10 | FDA UDI | Class II | Unknown |
| Z5m(t) | Z5m(t)-40-10 | FDA UDI | Class II | Active |
| Z5c | Z5c-A00 | FDA UDI | Class II | Unknown |
| Z5m(t) | Z5m(t)-50-12 | FDA UDI | Class II | Active |
| Z5_m_c_mt leer | Z5_m_c_mt leer | EUDAMEDFDA UDI | Class II | Active |
| Z5_Tray_Box | Z5_Tray_Box | EUDAMEDFDA UDI | Class II | Active |
| Z5m | Z5m-50-10 | EUDAMEDFDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-5010 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-40-10 | FDA UDI | Class II | Unknown |
| Z5-Bl | Z5-BL-4012 | EUDAMEDFDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-4012 | EUDAMEDFDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-5012 | EUDAMEDFDA UDI | Class II | Active |
| Z5m | Z5m-36-12 | EUDAMEDFDA UDI | Class II | Active |
| Z5m(t) | Z5m(t)-50-10 | FDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-3612 | EUDAMEDFDA UDI | Class II | Active |
| Bl-Osc-H | BL-OSC-H | FDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-5012 | EUDAMEDFDA UDI | Class II | Active |
| Z5m(t) | Z5m(t)-50-08 | FDA UDI | Class II | Active |
| Z5-Tl | Z5-TL-4010 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-50-08 | FDA UDI | Class II | Unknown |
| Z5c | Z5c-40-12 | FDA UDI | Class II | Unknown |
| Z5m | Z5m-36-10 | EUDAMEDFDA UDI | Class II | Active |
| Z5_m_c_mt Tray FULL | Z5_m_c_mt Tray FULL | EUDAMEDFDA UDI | Class II | Active |
| Z5-Bl | Z5-BL-5010 | EUDAMEDFDA UDI | Class II | Active |
| Z5c | Z5c-50-12 | FDA UDI | Class II | Unknown |
| Bl-Ost-H | BL-OST-H | EUDAMEDFDA UDI | Class II | Active |
| Z5mlb, Z5mlc | K131701 | FDA 510(k) | Class II | Active |
| Z5-Bl | K200386 | FDA 510(k) | Class II | Active |
| St-Z5 | K201878 | FDA 510(k) | Class II | Active |
| Z5-Bl | K190243 | FDA 510(k) | Class II | Active |
| Z-Look3 Evo Slm | K120793 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Z-Systems Ag Oensingen Solothurn · CH FEI 3006948427