BEUDAMED
    FDA Registration Active 🇨🇳 China

    Spark Clear Aligner System

    Reg #: 3031606517 · FEI: 3031606517 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Envista (Sichuan) Medical Device Co., Ltd.
    Registration Number
    3031606517
    FEI Number
    3031606517
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone A, B and C, Second Floor, Zone D, E-1, E2 and F, First Floor, Building A, No. 3 Xiandai Avenue
    City
    Ziyang Sichuan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203737

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1717 W. Collins Ave. Ca. 92867 USA, --
    City
    Orange
    State
    CA
    Postal Code
    92867
    Country
    US

    US Agent

    Business Name
    SYBRON DENTAL SPECIALTIES, INC.
    Contact Name
    Procoro Herrera
    Address
    Sybron Dental Specialties, Inc, 200 Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    657 3416074

    Products

    Device Name Product Code
    Aligner, Sequential NXC
    Orthodontic Software PNN

    Proprietary Names

    Spark Clear Aligner System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)