BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Perfit FS Dental Zirconia Fully Sintered Block

    Reg #: 1000426619 · FEI: 1000426619 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROLAND DGA
    Registration Number
    1000426619
    FEI Number
    1000426619
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15363 Barranca Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203590

    Owner / Operator

    Firm Name
    Roland DGA
    Operator Number
    10089780
    Address
    15363 Barranca Parkway
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Lisa Aguirre

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    Perfit FS Dental Zirconia Fully Sintered Block

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198