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Dmg USA, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
28

What Dmg USA, Inc. makes

Dmg USA, Inc. manufactures dental materials for restorative and preventive procedures, including temporary filling systems like LUXATEMP ULTRA/STAR, flowable composites such as MAGICFIL and LUXAFORM, and cavity liners like RETRACTION PASTE and STATUSBLUE. The portfolio also includes repair kits (COMPOSITE/COMPOMER REPAIR KIT), universal adhesives (LUXABITE), and dual-cure cements (PERMACEM DUAL). Nano-filled restorative kits (NANOCOMPOSITE RESTORATIVE KIT) and high-viscosity composites (LUXACORE DUAL) are designed for durable dental restorations, while TempoCem Clear and HONIGUM serve as temporary and permanent base materials, respectively.

The company’s products are regulated under FDA Class I, Class II, and Unclassified (U) designations, with many cleared via the 510(k) pathway. These materials are intended for use in dental offices and clinics in the United States, where compliance with FDA requirements ensures their safety and performance for restorative and preventive dental applications.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

Newest first, rows 1-28 of 28

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  • Luxatemp Ultra /Star Ref K101710

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

  • Magicfil Ref K013571

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

  • Luxaform Ref K000951

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

  • Retraction Paste Ref K130580

    Unclassified
    Active 510(k) 510(k) —

  • Statusblue Ref K013237

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

  • Composite/Compomer Repair Kit Ref K041960

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

  • TempoCem Clear Ref K160443

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

  • Nanocomposite Restorative Kit Ref K080480

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

  • Permacem / Permacem Dual Ref K012316

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

  • Luxabite Ref K013236

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

  • Honigum Ref K000878

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

  • Luxacore/Luxacore Dual Ref K012307

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

  • SA Flowable Adhesive Ref K102603

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

  • Luxaglaze Ref K013179

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

  • Self Adhesive Composite Luting Cement Ref K093338

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

  • Dental Mercury Ref K093587

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

  • Flowable Composite/ Ecuflow/ Luxaflow Ref K011211

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

  • Vitique System Ref K023649

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

  • Infiltration Kit Ref K081493

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

  • Luxatemp/Luxatemp Solar/Instatemp Ref K013674

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

  • Infiltration Kit Ref K100062

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

  • Total Etch Bonding Agent Ref K063444

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

  • Dental Ceramic Ref K080479

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

  • Tempocem Ref K110759

    Class I
    Active 510(k) 510(k) I

  • Provisional Inlay/Onlay Kit Ref K052800

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

  • Ecosite Bulk Fill Ref K171772

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

  • Primaflow Ref K002086

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

  • Luxaform Plus Ref K033227

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

Rows 1-28 of 28

Frequently asked questions

How many devices does Dmg USA, Inc. have in the registry?

The registry currently lists 28 devices for Dmg USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dmg USA, Inc.'s devices?

Among its 28 most recently registered devices, Dmg USA, Inc. has devices listed in FDA 510(k) (28 devices).

What risk classes do Dmg USA, Inc.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for Dmg USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Dmg USA, Inc. in the registry?

The most recently registered devices listed for Dmg USA, Inc. include LUXATEMP ULTRA /STAR, MAGICFIL, LUXAFORM and RETRACTION PASTE.

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