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510(k) Data Aggregation

    K Number
    K203072
    Device Name
    Franz Zirconia Dental Crown
    Manufacturer
    Franz Biotech Inc.
    Date Cleared
    2022-01-19

    (467 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Franz Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function. Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment. Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.
    Device Description
    Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function. Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment. Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques. The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.
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