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510(k) Data Aggregation

    K Number
    K242897
    Device Name
    Partial Flex
    Manufacturer
    Clemde Sa De Cv
    Date Cleared
    2025-06-03

    (253 days)

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

    Clemde Sa De Cv

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.
    Device Description
    Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).
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    K Number
    K233171
    Device Name
    PF Keep; Cad Cam Keep Block
    Manufacturer
    Clemde Sa De Cv
    Date Cleared
    2023-11-27

    (60 days)

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

    Clemde Sa De Cv

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PF KEEP / CAD CAM BLOCK IS A THERMO PLASTIC MATERIAL. THEY ARE INTENDED TO BE USED FOR THE MAANUFACTURE OF: I) FULL AND PARTIAL REMOVABLE DENTURES AND IMPLANT OVERDENTURES II)COPINGS, SUBSTRUCTURES (CEMENTED OR UNCEMENTED), FRAMEWORKS FOR PERMANENT AND TRANSITIONAL ANTERIOR OR POSTERIOR CROWNS AND BRIDGEWORKS.
    Device Description
    PF KEEP is a thermoplastic polymer, made from the polymer peek, is available as a granular material (so-called pellets) contained in plastic box with 45 g. that are used for manufacture of removable dental protheses. In case of CAD CAM PEEK BLOCK is for used with CAD CAM techniques. The material is provided nonsterile, without any accessories, and is a single use. The CAD CAM PEEK BLOCK are provided in different sizes.
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