BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALPHA-DENT® Paste & Paste Orthodontic Adhesive

    DI: D73530200000010 · Model: 302.0000.001 · DENTAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALPHA-DENT® Paste & Paste Orthodontic Adhesive
    Primary DI
    D73530200000010
    Version / Model
    302.0000.001
    Catalog Number
    302.0000.001
    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
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    00e94042-7b70-48a0-9815-ee58d89f004c

    Device Description

    ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 14g Catalyst Paste, 14g Base Paste, 1x 7ml Catalyst Bracket Bonding Resin, 1 x 7ml Base Bracket Bonding Resin, 7ml Etch Liquid, Spatulas, Mixing Pads

    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
    31750 Orthodontic bracket adhesive

    Identifiers

    Type ID
    Primary D73530200000010

    Customer Contacts

    Phone
    847-677-5500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K930614 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 27 Degrees Celsius