LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112188
    Device Name
    PIEZOTOME SOLO
    Manufacturer
    SATELEC - ACTEON, INC.
    Date Cleared
    2012-02-03

    (189 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    SATELEC - ACTEON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
    Device Description
    The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009). The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.
    Ask a Question

    Page 1 of 1