BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Porcelain Repair Kit (Clear)

    DI: D7796610153 · Model: 661015 · COSMEDENT, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Porcelain Repair Kit (Clear)
    Primary DI
    D7796610153
    Version / Model
    661015
    Catalog Number
    661015
    Company Name
    COSMEDENT, INC.
    Labeler DUNS
    113911689
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f877d65b-2fe1-4bd2-a529-64cc82f67ae4

    Device Description

    Porcelain Repair Kit (Clear) includes 1 (2.5 cc) PorcelETCH™ Clear, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    35877 Dental repair kit, ceramic

    Identifiers

    Type ID
    Primary D7796610153