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Z-Systems AG

Country not established FDA

Devices
69
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

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.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue69

Newest first, rows 1-50 of 69

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  • Z5m(t)-neo-4008

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo-4010

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo-4012

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo-5008

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo-5010

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo-5012

    Active Regimes: 510(k) Registry: GUDID Class:II

  • FD400-neo

    Listed Registry: GUDID Class:I

  • FD500-neo

    Listed Registry: GUDID Class:I

  • TD230-1

    Listed Registry: GUDID Class:I

  • TD285-1

    Listed Registry: GUDID Class:I

  • Z5m(t)-neo Insert

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-neo Tray Full

    Active Regimes: 510(k) Registry: GUDID Class:II

  • DP285-1

    Listed Registry: GUDID Class:I

  • DP230-1

    Listed Registry: GUDID Class:I

  • Z5m-50-08

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m-50-12

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5_m_c_mt Inlay

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Tl-4008

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5c-40-08

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5-Bl-3608

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5c-A15s

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5-BL_TL-leer

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m-40-08

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Bl-4008

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m(t)-40-08

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5-Bl-4010

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m(t)-40-12

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m-40-10

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Tl-5008

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5c-A00s

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m-40-12

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Bl-3610

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Bl-5008

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5c-50-10

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5m(t)-40-10

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5c-A00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bl-Ost

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m(t)-50-12

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5_m_c_mt leer

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5_Tray_Box

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m-50-10

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Tl-5010

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5c-40-10

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5-Bl-4012

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Tl-4012

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5-Bl-5012

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m-36-12

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Z5m(t)-50-10

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Z5-Bl-3612

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Bl-Osc-H

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

Rows 1-50 of 69

Showing 1-50 of 69

Company details

DUNS number
483189556
Phone
(877) 874 9407

FDA establishments1

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

  • Z-Systems AG Oensingen Solothurn · CH FEI 3006948427

Frequently asked questions

How many devices does Z-Systems AG have in the registry?

The registry currently lists 69 devices for Z-Systems AG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Z-Systems AG's devices?

Among its 50 most recently registered devices, Z-Systems AG has devices listed in EUDAMED (25 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Z-Systems AG's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Z-Systems AG's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Z-Systems AG in the registry?

The most recently registered devices listed for Z-Systems AG include Z5m(t)-neo-4008, Z5m(t)-neo-4010, Z5m(t)-neo-4012 and Z5m(t)-neo-5008.

Which FDA establishments are linked to Z-Systems AG?

1 FDA establishment is linked to Z-Systems AG in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.