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510(k) Data Aggregation

    K Number
    K082749
    Device Name
    OMNI-TIGHT
    Date Cleared
    2008-12-04

    (76 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).
    Device Description
    The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.
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    K Number
    K072595
    Device Name
    OMNI-TIGHT
    Date Cleared
    2008-05-09

    (238 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
    Device Description
    The B.A.S.I.C. Dental Implant is an endosseous dental implant. The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to). In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional.
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    K Number
    K022912
    Device Name
    POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
    Date Cleared
    2002-09-20

    (17 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BASIC Dental Implant System Post & Core - Thin Attachment is indicated for attaching artificial teeth to a dental implant.
    Device Description
    The Post and Core - Thin Attachment is a one-piece attachment. The base is cemented into a dental implant. Artificial teeth are then attached to the Post and Core - Thin using conventional techniques.
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    K Number
    K013682
    Device Name
    MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
    Date Cleared
    2001-11-28

    (21 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
    Device Description
    The BASIC Dental Implant is an endosseous dental implant.
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    K Number
    K012299
    Device Name
    MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
    Date Cleared
    2001-08-01

    (12 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.
    Device Description
    The Straight Post and Core II Attachment is a three-piece attachment. The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.
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    K Number
    K001259
    Device Name
    2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
    Date Cleared
    2001-01-12

    (268 days)

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

    BASIC DENTAL IMPLANT SYSTEMS, INC.

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