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510(k) Data Aggregation

    K Number
    K202092
    Device Name
    ABC Dental Implant System
    Date Cleared
    2021-09-23

    (422 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abracadabra Implants Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.
    Device Description
    ABC Dental Implant System is an internal hex implant system with one model of implant at this time. ABC dental implant is a slightly tapered cylindrical internal hex implant with micro-rings at the implant neck, which comes in 3.3. 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13, and 16. The 5.0 and 6.0 diameter implants do not come in a length of 16mm. All implants and abutments are made of ASTM F136 Ti 6A1 4V ELI. The implants have a grit blasted and acid etched surface. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. Straight abutments come in 5. 7, 9, or 11mm leneths and shouldered straight abutments come 1, 2, 3, or 4mm in height. Wide straight shoulder abutments come in heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 5, 7, 9, 11 mm. Smooth straight wide abutments come in lengths of 5, 7, 9, and 11 mm and the grooved version comes only in 9mm. 15° anatomic angulated abutments come in heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in heights of 1, 2, or 3mm. Straight multi-unit abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in heights of 0.5, 1.5, or 2.5 mm. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Straight multi-unit mounted dentures can only be removed by the dentist, but dentures mounted on flat abutments or ball attachments can be removed by the patient. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in heights of 2, 3, 4, and 5 mm.
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