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510(k) Data Aggregation

    K Number
    K143292
    Device Name
    TheraCal DC
    Manufacturer
    Bisco Inc
    Date Cleared
    2015-08-04

    (260 days)

    Product Code
    EJK, CLA
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bisco Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TheraCal DC is indicated for use for: - 1. Pulpotomy - 2. Temporary filling material - 3. Repair of root perforations - Repair of furcation perforations 4. - 5. Repair of perforating internal and external resorptions - 6. Root-end filling in endodontic surgery - 7. Pulp exposures (direct pulp capping) - 8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates
    Device Description
    TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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