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Z-Systems AG

US Last updated 27 May 2026

Devices
69
Registries
GUDIDEUDAMEDFDA
FDA recalls
0

Catalogue69

Page 1 of 2

  • Z5m(t)-neo-4008 Ref Z5m(t)-neo-4008

    Class II FDA UDI Active

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    Class II FDA UDI Active

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    Class II FDA UDI Active

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    Class II FDA UDI Active

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    Class II FDA UDI Active

  • Z5m(t)-neo-5012 Ref Z5m(t)-neo-5012

    Class II FDA UDI Active

  • FD400-neo Ref FD400-neo

    Class I FDA UDI Active

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    Class I FDA UDI Active

  • TD230-1 Ref TD230-1

    Class I FDA UDI Active

  • TD285-1 Ref TD285-1

    Class I FDA UDI Active

  • Z5m(t)-neo Insert Ref Z5m(t)-neo Insert

    Class II FDA UDI Active

  • Z5m(t)-neo Tray Full Ref Z5m(t)-neo Tray Full

    Class II FDA UDI Active

  • DP285-1 Ref DP285-1

    Class I FDA UDI Active

  • DP230-1 Ref DP230-1

    Class I FDA UDI Active

  • Z5m-50-08 Ref Z5m-50-08

    Class II EUDAMEDFDA UDI Active

  • Z5m-50-12 Ref Z5m-50-12

    Class II EUDAMEDFDA UDI Active

  • Z5_m_c_mt Inlay Ref Z5_m_c_mt Inlay

    Class II EUDAMEDFDA UDI Active

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    Class II EUDAMEDFDA UDI Active

  • Z5c-40-08 Ref Z5c-40-08

    Class II FDA UDI

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    Class II EUDAMEDFDA UDI Active

  • Z5c-A15s Ref Z5c-A15s

    Class II FDA UDI Active

  • Z5-BL_TL-leer Ref Z5-BL_TL-leer

    Class II EUDAMEDFDA UDI Active

  • Z5m-40-08 Ref Z5m-40-08

    Class II EUDAMEDFDA UDI Active

  • Z5-Bl-4008 Ref Z5-BL-4008

    Class II EUDAMEDFDA UDI Active

  • Z5m(t)-40-08 Ref Z5m(t)-40-08

    Class II FDA UDI Active

  • Z5-Bl-4010 Ref Z5-BL-4010

    Class II EUDAMEDFDA UDI Active

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    Class II FDA UDI Active

  • Z5m-40-10 Ref Z5m-40-10

    Class II EUDAMEDFDA UDI Active

  • Z5-Tl-5008 Ref Z5-TL-5008

    Class II EUDAMEDFDA UDI Active

  • Z5c-A00s Ref Z5c-A00s

    Class II FDA UDI Active

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    Class II EUDAMEDFDA UDI Active

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    Class II EUDAMEDFDA UDI Active

  • Z5-Bl-5008 Ref Z5-BL-5008

    Class II EUDAMEDFDA UDI Active

  • Z5c-50-10 Ref Z5c-50-10

    Class II FDA UDI

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    Class II FDA UDI Active

  • Z5c-A00 Ref Z5c-A00

    Class II FDA UDI

  • Bl-Ost Ref BL-OST

    Class II EUDAMEDFDA UDI Active

  • Z5m(t)-50-12 Ref Z5m(t)-50-12

    Class II FDA UDI Active

  • Z5_m_c_mt leer Ref Z5_m_c_mt leer

    Class II EUDAMEDFDA UDI Active

  • Z5_Tray_Box Ref Z5_Tray_Box

    Class II EUDAMEDFDA UDI Active

  • Z5m-50-10 Ref Z5m-50-10

    Class II EUDAMEDFDA UDI Active

  • Z5-Tl-5010 Ref Z5-TL-5010

    Class II EUDAMEDFDA UDI Active

  • Z5c-40-10 Ref Z5c-40-10

    Class II FDA UDI

  • Z5-Bl-4012 Ref Z5-BL-4012

    Class II EUDAMEDFDA UDI Active

  • Z5-Tl-4012 Ref Z5-TL-4012

    Class II EUDAMEDFDA UDI Active

  • Z5-Bl-5012 Ref Z5-BL-5012

    Class II EUDAMEDFDA UDI Active

  • Z5m-36-12 Ref Z5m-36-12

    Class II EUDAMEDFDA UDI Active

  • Z5m(t)-50-10 Ref Z5m(t)-50-10

    Class II FDA UDI Active

  • Z5-Bl-3612 Ref Z5-BL-3612

    Class II EUDAMEDFDA UDI Active

  • Bl-Osc-H Ref BL-OSC-H

    Class II EUDAMEDFDA UDI Active

Showing 1-50 of 69

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Z-Systems AG Oensingen Solothurn · CH FEI 3006948427

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
Website
zsystems.com
Phone
(877) 874 9407
DUNS number
483189556