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510(k) Data Aggregation

    K Number
    K240725
    Device Name
    PreXolid CAD/CAM abutments
    Manufacturer
    Date Cleared
    2024-10-18

    (214 days)

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

    Eclectic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PreXolid CAD/CAM Abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in the prosthetic rehabilitation.
    Device Description
    The subject patient-specific abutment, PreXolid CAD/CAM Abutment used in fabricating fully patient-specific abutments made of Ti-6A1-4V ELI, conforming to ASTM Standard F136. Each patient-specific abutment is individually prescribed by the clinician. The subject devices are available in diameters ranging from 5.0mm. The subject device is provided with an abutment screw. PreXolid CAD/CAM Abutments are compatible with XPEED AnyRidge Internal Implant System (K12231). The allowable ranges of design parameters after CAD/CAM patient-matching are as follows: Minimum wall thickness(mm): 0.45 Maximum angulation(°): 25 Minimum gingival collar height(mm): 2.00 Maximum gingival collar height(mm): 5.00 Minimum gingival collar(ø): 4.00 Maximum gingival collar(ø): 9.50 , 11.50 Minimum post height (mm): 4.00 Maximum post height (mm): 6.00 The subject abutments are provided non-sterile and are intended to be sterilized by the clinician. Materials: Pre-milled abutments and screws are fabricated from Ti-6A1-4V ELI, conforming to ASTM Standard F136.
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