BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Caulk® 50% Tooth Conditioner Liquid For Etching Enamel

    DI: D0026460091 · Model: 646009 · DENTSPLY INTERNATIONAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

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    Basic Information

    Brand Name
    Caulk® 50% Tooth Conditioner Liquid For Etching Enamel
    Primary DI
    D0026460091
    Version / Model
    646009
    Catalog Number
    646009
    Company Name
    DENTSPLY INTERNATIONAL INC.
    Labeler DUNS
    083235549
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    3
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    9c427d16-f7a2-4bfb-9961-44185fb433ae

    Device Description

    Caulk® 50% Tooth Conditioner Liquid Package, 2 (10ml) bottle Refill

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    Yes
    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
    EBC SEALANT, PIT AND FISSURE, AND CONDITIONER

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary D0026460091
    Unit of Use D0026460090

    Customer Contacts

    Phone
    +1(800)532-2855
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 10 Milliliter
    Device Size Text, specify 2 Bottles Caulk® 50% Tooth Conditioner Liquid (10mL each)

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius