BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alpha-Crown®

    DI: D73511300060020 · Model: 113.0006.002 · DENTAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alpha-Crown®
    Primary DI
    D73511300060020
    Version / Model
    113.0006.002
    Catalog Number
    113.0006.002
    Company Name
    DENTAL TECHNOLOGIES, INC.
    Labeler DUNS
    148312838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    e4a2282c-7c58-406f-bbdc-d77457ae525d

    Device Description

    Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns and bridges with ease and convenience. The static mixing tip provides automatic mixing from the dual chambered cartridge to greatly reduce in-office procedure time. The Bix-acryl material is very durable, color stable, and water resistant. The greater flexibility facilitates deformation free removal of the material from the patient's mouth. Alpha-Crown® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 74g Cartridge (Shade A2), 10 Automix Tips

    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

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary D73511300060020

    Customer Contacts

    Phone
    847-677-5500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K960122 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 27 Degrees Celsius