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510(k) Data Aggregation

    K Number
    K211871
    Device Name
    FAICO Dental Implant System and CAD/CAM Abutments
    Manufacturer
    Date Cleared
    2021-11-18

    (154 days)

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

    Faico Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Faico Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. FAICO CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom- milled in accordance with a patient- specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/ CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (singletooth) or multiple-unit (bridges and bars) restorations and are compatible for use with FAICO Dental Implants with internal hex- connection mating platform and conical connection platform diameters. All digitally designed abutments and/or copings for use with FAICO CAD/CAM Abutments are intended to be sent to a FAICO-validated milling center for manufacture. FAICO abutments designed using CAD/CAM techniques must fulfill the FAICO allowable range of design parameters.
    Device Description
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    K Number
    K191997
    Device Name
    FAICO CMF System
    Manufacturer
    Date Cleared
    2020-04-22

    (271 days)

    Product Code
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    FAICO Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FAICO CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed.
    Device Description
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    K Number
    K192015
    Device Name
    Faico Dental Implant System
    Manufacturer
    Date Cleared
    2020-04-03

    (249 days)

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

    FAICO Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
    Device Description
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