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510(k) Data Aggregation

    K Number
    K211345
    Device Name
    C-30 Crown Kit
    Date Cleared
    2021-11-24

    (205 days)

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

    Perfect Fit Crowns, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The C-30 Crowns are indicated for the use as a permanent Posterior Dental Crown
    Device Description
    The C-30 Crown Kit is a permanent tooth solution for single-unit restoration, adhesively cemented. The C-30 Crown Kit contains 3 components required for the chairside direct assembly of a posterior permanent crown. 1. The C-30 Sleeve, manufactured from VarseoSmile Crown Plus the 510(k) cleared (K201668) material has an external aspect that matches the internal aspect of the C-30 Crown, also manufactured with the same VarseoSmile Crown Plus (K201668) 510(k) cleared material. This material is a light cured, ceramic filled, methacrylate-based resin for the production of permanent single crowns. The sleeve is used as a containment vessel holding the 510(k) cleared Visalys CemCore, Visalys Cem Core Try In Paste (K191527) Adhesive Cement & CoreBuild-up which surrounds the prepared tooth created by the dentist. This match of the two units assures a perfect fit with a minimal gap of 5-15 microns between the C-30 Crown and the C-30 Sleeve. 2. The Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) is used to treat the bonding surface of the sleeveand the Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) is used to fill up the gap between the prepped tooth structure and the C-30 Sleeve. Once bonded and cured, the process continues. 3. The C-30 Crown now fits perfectly over the C-30 Sleeve and is bonded in place with the Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) used consistent with its instructions for use.
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