BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DENKEN-HIGHDENTAL Co., Ltd.

    Reg #: 3010564008 · FEI: 3010564008 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DENKEN-HIGHDENTAL Co., Ltd.
    Registration Number
    3010564008
    FEI Number
    3010564008
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    24-3 Kisshoin Ishiharakyomichi-Cho, Minami-ku
    City
    Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K221429

    Owner / Operator

    Firm Name
    DENKEN-HIGHDENTAL Co., Ltd.
    Operator Number
    10045737
    Address
    24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku
    City
    Kyoto
    State
    JP-26
    Postal Code
    601-8356
    Country
    JP

    US Agent

    Business Name
    FDC Services LLC
    Contact Name
    David FURR
    Address
    7120 Via Correto Dr
    City
    Austin
    State
    TX
    ZIP
    78749
    Country
    US
    Email
    [email protected]
    Phone
    512 9069654

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Wax, Dental, Intraoral EGD

    Proprietary Names

    KDF Zirconia Disc Super Primer Rezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super Primer AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase Kolben Wax, Sprue Wax

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device