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510(k) Data Aggregation

    K Number
    K123861
    Device Name
    AIDI DENTAL IMPLANT SYSTEM
    Manufacturer
    AIDI BIOMEDICAL LLC
    Date Cleared
    2013-12-12

    (363 days)

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

    AIDI BIOMEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.
    Device Description
    The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments (which provide cemented and screw retained restorative options), cover screws, abutment screws, and healing abutments.
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    K Number
    K101755
    Device Name
    AIDI DENTAL IMPLANT SYSTEM
    Manufacturer
    AIDI BIOMEDICAL LLC
    Date Cleared
    2010-11-22

    (152 days)

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

    AIDI BIOMEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with AIDT Dental implant Systembents intended to be surgically placed in the Sorews) are enabose lower jaw arches to provide support for prosthetic bone of the upper of artificial tooth, in order to restore patient esthetics deviocs, suon ao an arming abutments indicated for both screw and chewing function. Straigrations are included. The implants are indicated for single or multiple unit restorations and can be used in indicator for oingle applications. The device is intended for Splinted and non opinious appress and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
    Device Description
    AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options. AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM). The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.
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