BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acero NS

    Reg #: 3006007013 · FEI: 3006007013 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PARK-ISTRE, LLC.
    Registration Number
    3006007013
    FEI Number
    3006007013
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4001 McEwen Rd, STE. 408
    City
    DALLAS
    State
    TX
    ZIP
    75244
    Country
    US

    Owner / Operator

    Firm Name
    PARK-ISTRE, LLC.
    Operator Number
    9093900
    Address
    4001 McEwen Rd., STE. 408
    City
    Dallas
    State
    TX
    Postal Code
    75244
    Country
    US
    Correspondent
    CHAD C PARK

    Products

    Device Name Product Code
    Crown, Preformed ELZ

    Proprietary Names

    Acero NS Acero ESL Crowns Acero ES Crowns Acero 3S Crowns Acero Narrow NA Crowns Acero XT Crowns Acero Z1 Crowns

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility