BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spark Clear Aligner System

    Reg #: 3015272949 · FEI: 3015272949 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Ormco Corporation
    Registration Number
    3015272949
    FEI Number
    3015272949
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    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

    Products

    Device Name Product Code
    Aligner, Sequential NXC
    Orthodontic Software PNN

    Proprietary Names

    Spark Clear Aligner System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198