Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K241056
    Device Name
    Light Cure Adhesive
    Manufacturer
    Sincera Technology (Changchun) Co., Ltd.
    Date Cleared
    2024-07-16

    (89 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sincera Technology (Changchun) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures: - Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives; - Repair of dental restorations of ceramic, composites and/or metal alloys; - Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
    Device Description
    Not Found
    Ask a Question
    K Number
    K240112
    Device Name
    Light Cure Composite
    Manufacturer
    Sincera Technology (Changchun) Co., Ltd.
    Date Cleared
    2024-03-15

    (59 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sincera Technology (Changchun) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
    Device Description
    Light Cure Composite is a state-of-the-art light-curing, radiopaque, nano-hybrid composite for the restorative therapy. The device cures with light at the wavelength range of 400–500 nm (blue light). The device is paste contained in PP syringe.
    Ask a Question

    Page 1 of 1