Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K180598
    Device Name
    UNIQA Dental Implants System
    Manufacturer
    UNIQA DENTAL LTD
    Date Cleared
    2018-08-08

    (154 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIQA DENTAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
    Device Description
    UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design:(a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;
    Ask a Question

    Page 1 of 1