BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alpha-Seal®

    DI: D73540101030020 · Model: 401.0103.002 · DENTAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alpha-Seal®
    Primary DI
    D73540101030020
    Version / Model
    401.0103.002
    Catalog Number
    401.0103.002
    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
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    51ec993f-7db7-4639-89a5-37d90cf33566

    Device Description

    Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Opaque White), 3 Dispensing Tips

    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
    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
    EBC Sealant, Pit And Fissure, And Conditioner

    GMDN Terms

    Code Name
    31780 Dental pit/fissure sealant

    Identifiers

    Type ID
    Primary D73540101030020

    Customer Contacts

    Phone
    847-677-5500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K924635 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 27 Degrees Celsius