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Vivadent (Usa), Inc.

United StatesFDA 510(k) applicant, unverified

Devices
17

What Vivadent (Usa), Inc. makes

Vivadent (USA), Inc. manufactures dental adhesives, bonding agents, and restorative materials, including resin-based bonding systems like HELIOBOND and CONTACT RESIN, as well as colorants for dental restorations. Their portfolio also includes silane coupling agents (SILANIT), dental silicophosphate cements (BONDALCAP), and composite resins (REOLIT, ISOPLAST, ISOPAST-DS). Additional products include dental sealants (CONTACT SEAL), amalgam bonding agents (AMALCAP-NON-GAMMA-2), and curing lights (HELIOSIT, HELIOMAT).

These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) registry, reflecting their authorised status for dental use in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue17

Newest first, rows 1-17 of 17

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  • Heliobond Ref K802681

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

  • Contact Resin Ref K790439

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

  • Colorant Ref K790438

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

  • Bondalcap (Silico-Phosphate) Ref K801228

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

  • Heliosit Ref K802683

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

  • Silanit Ref K802679

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

  • Reolit Ref K802685

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

  • Isoplast Ref K781787

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

  • Isopast-Ds Ref K802680

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

  • Heliomat Ref K802684

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

  • Contact Seal Ref K802682

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

  • Amalcap-Non-Gamma-2 Ref K790874

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

  • Vivadent Filpin Ref K863831

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

  • Silicap Ref K801227

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

  • Bondalcap (Carboxylate) Ref K801229

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

  • Helioseal Ref K813015

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

  • Heliosit-Orthodontic Ref K823409

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

Rows 1-17 of 17

Frequently asked questions

How many devices does Vivadent (Usa), Inc. have in the registry?

The registry currently lists 17 devices for Vivadent (Usa), Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vivadent (Usa), Inc.'s devices?

Among its 17 most recently registered devices, Vivadent (Usa), Inc. has devices listed in FDA 510(k) (17 devices).

What risk classes do Vivadent (Usa), Inc.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Vivadent (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 Vivadent (Usa), Inc. in the registry?

The most recently registered devices listed for Vivadent (Usa), Inc. include HELIOBOND, CONTACT RESIN, COLORANT and BONDALCAP (SILICO-PHOSPHATE).

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