BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Super Primer

    Reg #: 3010564008 · FEI: 3010564008 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DENKEN-HIGHDENTAL Co., Ltd.
    Registration Number
    3010564008
    FEI Number
    3010564008
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    24-3 Kisshoin Ishiharakyomichi-Cho, Minami-ku
    City
    Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K130680

    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

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device