BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KDF Zirconia Disc

    Reg #: 3010564008 · FEI: 3010564008 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    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

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    KDF Zirconia Disc

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device