BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Spark Clear Aligner System

    Reg #: 3028340833 · FEI: 3028340833 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EH Labs CZ s.r.o.
    Registration Number
    3028340833
    FEI Number
    3028340833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vorlesska 3281
    City
    Dvur Kralove nad Labem Hradec Kralove
    Country
    CZ

    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)