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Kuraray America, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
11

What Kuraray America, Inc. makes

Kuraray America, Inc. manufactures dental adhesives and restorative materials, including bonding agents like Clearfil Tri-S Bond Plus and Alloy Primer, as well as composite resins such as Clearfil Majesty Posterior and Panavia F for dental restorations. Their portfolio also includes surface treatment coatings, chromatic stain solutions, and liner bonding systems designed for dental procedures.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for dental use in the United States.

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

Catalogue11

Newest first, rows 1-11 of 11

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  • Clearfil Majesty Flow Ref K063593

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

  • Clearfil Dc Core Plus Ref K111982

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

  • Modification To Panavia F Ref K002322

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

  • Clearfil Tri-S Bond Plus Ref K111980

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

  • Surface Coat Ref K063228

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

  • Clearfil Liner Bond 2V Ref K974486

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

  • Chroma Zone Color Stain Ref K982259

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

  • Estenia Ref K982164

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

  • Alloy Primer Ref K974089

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

  • Panavia F Ref K983361

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

  • Clearfil Majesty Posterior Ref K063595

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Kuraray America, Inc. have in the registry?

The registry currently lists 11 devices for Kuraray America, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kuraray America, Inc.'s devices?

Among its 11 most recently registered devices, Kuraray America, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Kuraray America, Inc.'s devices fall under?

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

What are the newest devices from Kuraray America, Inc. in the registry?

The most recently registered devices listed for Kuraray America, Inc. include CLEARFIL MAJESTY FLOW, CLEARFIL DC CORE PLUS, MODIFICATION TO PANAVIA F and CLEARFIL TRI-S BOND PLUS.

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