BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hydroxyline

    DI: D8370545000 · Model: Thinner - TC - 12cc · Taub Products
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Hydroxyline
    Primary DI
    D8370545000
    Version / Model
    Thinner - TC - 12cc
    Catalog Number
    05-4500
    Company Name
    Taub Products
    Labeler DUNS
    067488114
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-26
    Public Version
    3
    Public Version Date
    2025-07-14
    Public Version Status
    Update
    Public Device Record Key
    98903d66-cc69-4d47-8355-b2152a970999

    Device Description

    HYDROXYLINE - Calcium Hydroxide Cavity Liner TC Thinner is used to thin out the Liquid due to evaporation or need to change viscosity. Hydroxyline is a thin 'varnish' film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and 'pulp' shock.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EJK Liner, Cavity, Calcium Hydroxide

    GMDN Terms

    Code Name
    35698 Dental cavity varnish

    Identifiers

    Type ID
    Primary D8370545000

    Customer Contacts

    Phone
    +1.201.798.5353
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 12 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from open flame. See SDS.