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510(k) Data Aggregation

    K Number
    K112099
    Device Name
    CONTOUR HEALER
    Manufacturer
    CONTOUR HEALER, LLC
    Date Cleared
    2012-02-03

    (196 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTOUR HEALER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed. These abutments are designed to work with the following implant systems: Zimmer [Screw-Vent Dental Implant System] Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Impiant, Nobel Biocare Endosseous Implants, and Groovy Implants] BioHorizons [BioHorizons·Tapered Internal Implant System].
    Device Description
    The Contour Healer. LLC product line includes pre-manufactured dental abutments intended to serve as a temporary dental prosthesis during the healing process until a permanent crown is fabricated. The abutment is made of PEEK Classix and is directly connected to the endosseous dental abutment by a stainless steel screw. These abutments have biconvex domes to mimic emergence of the original tooth morphology. and therefore provide for a more esthetic gingival contour during the restorative phase. The abutments come in several abutment- to-implant diameters. The abutments are intended for single-use not to exceedninety days. At the end of the treatment period, the temporary abutment is to be removed by clinician and the permanent crown is installed.
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