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510(k) Data Aggregation

    K Number
    K122348
    Device Name
    QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
    Date Cleared
    2012-10-15

    (73 days)

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

    RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work - QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ reinforcement - QUARTZ SPLINT™ WOVEN: Direct Splinting/Bridge and Implant positioning reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy. - OUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or denture repair .- Periodontal splinting of mobile teeth in Clinical use. - QUARTZ SPLINT™ MESH: Denture reinforcement and denture repair. - QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished splints - QS FLOWTM: a nano filled, light cured flowable composite designed to be used with the QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
    Device Description
    Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint is a complete system that contains different structures and it is available in different structures and sizes: Quartz Splint UD Quartz Splint WOVEN Ouartz Splint ROPE Quartz Splint MESH Ouartz Splint Resin/Flow
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