BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ECLIPSE 2

    Reg #: 3014945384 · FEI: 3014945384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMSUSA
    Registration Number
    3014945384
    FEI Number
    3014945384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4025 Pleasantdale Rd, STE 540
    City
    Atlanta
    State
    GA
    ZIP
    30340
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163238

    Owner / Operator

    Firm Name
    AMSUSA
    Operator Number
    10058826
    Address
    4025 Pleasantdale Rd, STE 540
    City
    Atlanta
    State
    GA
    Postal Code
    30340
    Country
    US
    Correspondent
    Youngjin Kim

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    ECLIPSE 2 ECLIPSE KISS Zirconia ECLIPSE Coloring Liquid ECLIPSE 2 PLUS ECLIPSE KISS ECLIPSE KISS Coloring Liquid ECLIPSE 1 ECLIPSE KISS PLUS ECLIPSE Multi Layer

    Establishment Types

    Manufacture Medical Device