LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K073121
    Device Name
    NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
    Manufacturer
    NUBRACE, INC.
    Date Cleared
    2009-02-12

    (465 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUBRACE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NuBrace IRO is indicated for the treatment of tooth malocclusion and for preprosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.
    Device Description
    The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.
    Ask a Question

    Page 1 of 1