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510(k) Data Aggregation

    K Number
    K961381
    Device Name
    KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1997-09-09

    (539 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic load is incorporated into the implant sites.
    Device Description
    Endosseous implant system consists of implants, tools and prosthetic abutments. This submission includes premachine angulated abutments less than 30°, specifically included are 15 and 25° abutments. In addition, in the wide body series there are a series of one and two piece prosthetic abutments with 4, 5, and 6mm platform diameters. These diameters match with the platform diameters of the appropriate implant bodies included in this system. This system includes cylindrical and screw implants of a variety of lengths and geometrical shapes. These devices are similar in their intended use and follow the appropriate integration protocol phase and following prosthetic attachments.
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    K Number
    K961382
    Device Name
    MT1A
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.
    Device Description
    Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
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    K Number
    K961383
    Device Name
    MT1
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.
    Device Description
    Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
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    K Number
    K961384
    Device Name
    MT-2
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.
    Device Description
    system consists of Endosseous implant implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
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    K Number
    K961385
    Device Name
    MT-3A
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to eacilitate the prosthetic phase and installation of the prosthesis for the patient.
    Device Description
    Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
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    K Number
    K961386
    Device Name
    MT-2A
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.
    Device Description
    Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
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    K Number
    K961387
    Device Name
    MT-X
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

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

    THE EMERGING TECHNOLOGIES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prospectives consideration for for the patient.
    Device Description
    Endosseous implant system consists of implants, tools and abutments long the submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prostheric attachments are fabricated to these abutments.
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