BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Glidewell HT™ Implant Surgical Kit (new)

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PRISMATIK DENTALCRAFT, INC.
    Registration Number
    3011649314
    FEI Number
    3011649314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242564

    Owner / Operator

    Firm Name
    PRISMATIK DENTALCRAFT, INC.
    Operator Number
    10043585
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    Michelle Gallup

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    Glidewell HT™ Implant Surgical Kit (new) Autoclavable Cassette for Glidewell HT™ Implant Surgical Kit Autoclavable Cassette for Glidewell™ Prosthetic Kit Glidewell HT™ Implant Guided Surgical Kit (new) Autoclavable Cassette for Glidewell HT™ Implant Guided Surgical Kit Glidewell™ Prosthetic Kit (new)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198