BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visalys CemCore

    DI: E217135701 · Model: 13570 · Kettenbach GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Visalys CemCore
    Primary DI
    E217135701
    Version / Model
    13570
    Catalog Number
    13570
    Company Name
    Kettenbach GmbH & Co. KG
    Labeler DUNS
    316803246
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-25
    Public Version
    1
    Public Version Date
    2019-12-03
    Public Version Status
    New
    Public Device Record Key
    fa9f47dc-8446-42ec-afd9-37c2a477fe43

    Device Description

    Visalys CemCore Universal (A2/A3) Starter pack 1 x 2,5 ml VCC, 2 ml TP, 2 ml RP + Accessories

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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

    Product Codes

    Code Name
    EBF Material, Tooth Shade, Resin
    KLE Agent, Tooth Bonding, Resin

    GMDN Terms

    Code Name
    62477 Dental composite resin kit

    Identifiers

    Type ID
    Primary E217135701