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Zhermack Dental Production

Country not established

Devices
11

What Zhermack Dental Production makes

Zhermack Dental Production manufactures dental impression materials, including putty-based systems like ZETAPLUS and ELITE PUTTY variants, light-body and regular-body impression compounds (e.g., ELITE LIGHT BODY, ELITE REGULAR BODY), and specialized gels such as INDURENT GEL. The portfolio also includes occlusal registration materials like OCCLUFAST and hydrocolloid-based products such as HYDROGUM, as well as thixotropic impression pastes like THIXOFLEX.

These dental devices are classified under Class II in the U.S. and are listed via 510(k) clearance through the FDA. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

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  • Zetaplus (Putty) Ref K935890

    Class II
    Active 510(k) 510(k) II

  • Elite Putty Hard Ref K931242

    Class II
    Active 510(k) 510(k) II

  • Elite Regular Body Ref K935887

    Class II
    Active 510(k) 510(k) II

  • Thixoflex Ref K935896

    Class II
    Active 510(k) 510(k) II

  • Elite Fast Light Body Ref K935888

    Class II
    Active 510(k) 510(k) II

  • Elite Light Body Ref K935886

    Class II
    Active 510(k) 510(k) II

  • Hydrogum Ref K935898

    Class II
    Active 510(k) 510(k) II

  • Occlufast Ref K935889

    Class II
    Active 510(k) 510(k) II

  • Elite Putty Soft Ref K935884

    Class II
    Active 510(k) 510(k) II

  • Indurent Gel Ref K935892

    Class II
    Active 510(k) 510(k) II

  • Elite Fast Putty Soft Ref K935885

    Class II
    Active 510(k) 510(k) II

Rows 1-11 of 11

Frequently asked questions

How many devices does Zhermack Dental Production have in the registry?

The registry currently lists 11 devices for Zhermack Dental Production. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zhermack Dental Production's devices?

Among its 11 most recently registered devices, Zhermack Dental Production has devices listed in FDA 510(k) (11 devices).

What risk classes do Zhermack Dental Production's devices fall under?

Among its 11 most recently registered devices, the classes recorded for Zhermack Dental Production's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Zhermack Dental Production in the registry?

The most recently registered devices listed for Zhermack Dental Production include ZETAPLUS (PUTTY), ELITE PUTTY HARD, ELITE REGULAR BODY and THIXOFLEX.

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