BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hyramic CAD/CAM Restorative

    Reg #: 3019596325 · FEI: 3019596325 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    UPCERA DENTAL AMERICA INC.
    Registration Number
    3019596325
    FEI Number
    3019596325
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13100 Alondra Blvd. Ste. 105
    City
    Cerritos
    State
    CA
    ZIP
    90703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162323

    Owner / Operator

    Firm Name
    Upcera Dental America Inc.
    Operator Number
    10082186
    Address
    13100 Alondra Blvd. Ste. 105
    City
    Cerritos
    State
    CA
    Postal Code
    90703
    Country
    US
    Correspondent
    Kevin Arakelyan

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    Hyramic CAD/CAM Restorative

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device