BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CompCore AF

    Reg #: 2511556 · FEI: 2511556 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PREMIER DENTAL PRODUCTS CO.
    Registration Number
    2511556
    FEI Number
    2511556
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1710 Romano Dr
    City
    PLYMOUTH MEETING
    State
    PA
    ZIP
    19462
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012160

    Owner / Operator

    Firm Name
    Premier Dental Products Company
    Operator Number
    2511556
    Address
    1710 ROMANO DR., --
    City
    Plymouth Meeting
    State
    PA
    Postal Code
    19462
    Country
    US
    Correspondent
    Jessica Huang

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    CompCore AF

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility