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510(k) Data Aggregation

    K Number
    K974280
    Device Name
    ABUTMENT - COMPLETE
    Date Cleared
    1998-02-20

    (107 days)

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

    THE IMPLANT CENTER OF THE PALM BEACHES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.
    Device Description
    The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.
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    K Number
    K960111
    Device Name
    KIS MT4
    Date Cleared
    1996-03-27

    (76 days)

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

    THE IMPLANT CENTER OF THE PALM BEACHES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 proBthetic phase and installation of the programs of the program and 824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 FAX (407) 627-4214 "Tomorrow's Technology Today"
    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
    K960110
    Device Name
    KIS MT3
    Date Cleared
    1996-03-20

    (69 days)

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

    THE IMPLANT CENTER OF THE PALM BEACHES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 programs and institute Moza Suite 302 for the patient.
    Device Description
    Endosseous implant system tools and consists of implants, 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
    K960112
    Device Name
    KIS MT5
    Date Cleared
    1996-03-15

    (64 days)

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

    THE IMPLANT CENTER OF THE PALM BEACHES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 proBthetic phase and installation of the progressions who works we 302 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
    K955048
    Device Name
    KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
    Date Cleared
    1996-01-11

    (69 days)

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

    THE IMPLANT CENTER OF THE PALM BEACHES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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