Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K102207
    Device Name
    FIBER FORCE
    Date Cleared
    2010-11-23

    (110 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCA MARKETING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    · As structural reinforcement for fabricating and/or repairing removable prostheses (dentures) and removable implant supported dentures (ISDs) · As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges. · As reinforcement for customized splints used to immobilize teeth which may be required for orthodontia, periodontia, traumatology and any dental activity requiring bonding of natural teeth.
    Device Description
    Fiber Force is a system of light-cured resin pre-impregnated E-glass fibers used for reinforcement in a variety of applications in dentistry. All formats of Fiber Force use specially treated E-glass fibers that impregnated in resin using an industrialized process that ensures homogeneity with the acrylic or composite resin interface material.
    Ask a Question

    Ask a specific question about this device

    K Number
    K062237
    Device Name
    CADI, VERSION 4
    Date Cleared
    2006-11-20

    (110 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCA MARKETING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient. CADI is a prescription use only product, intended to be used by dental professionals only.
    Device Description
    CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner. It is a modular software with the following modules: Digital x-ray module, Intraoral Camera Module, Digital Camera Module, Cosmetic and Whitening Module, Natural Smiles Library, and Orthocephalometric Tracing (DFO) Module.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1