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510(k) Data Aggregation

    K Number
    K982576
    Device Name
    FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-10-22

    (90 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH ABUTMENTS LABORATORY-AND CUSTOM RESTORATIONS, CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.
    Device Description
    The FRIALIT-2® AuroBase abutment is a one part abutment with two working areas, a gold cvlinder and a plastic sleeve. The gold cylinder has as the rotational securing device a hexagon, which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The plastic sleeve molded around the gold cylinder and is color-coded in order to differentiate the different diameters. The diameters of the FRIALIT-2® AuroBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: Ø3.8 mm. Ø4.5 mm, Ø5,5 mm and Ø6,5 mm. The FRIALIT-2® AuroBase gold cylinder is manufactured out of a commercial gold alloy. The FRIALIT-2® AuroBase plastic sleeve is manufactured out of a burnable commercial plastic.
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    K Number
    K980630
    Device Name
    FRIALIT-2 CORABASE
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-09-04

    (198 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.
    Device Description
    The FRIALIT-2® CeraBase abutment is a two part abulment. It consists of the titanium insert and the caramic sleeve. The titanium insert has as the rotational securing device a hexagon. which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The ceramic sleeve is blaced on top of the titanium insert where it is rotationally secured by a slot and key connection. The titanium insert is color-coded in order to clearly differentlate the different diameters. The diameters of the FRIALIT-2® CeraBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: D3,8 mm, D4,5 mm, D5,5 mm and D6,5 mm. The FRIALIT-2® CaraBase titanium insert is manufactured out of pure titanium grade II material which is in accordance to ASTM F 67 'Standard Specification for Unalloyed Titanium for Surgical Implant Application'. The FRIALIT-209 CeraBase ceramic sleeve is manufactured out of medical grade aluminumdioxid ceramic which Is In accordance to ASTM F 603 'Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application'.
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    K Number
    K973924
    Device Name
    FRIOS BONESHIELD
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-05-07

    (204 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Friatec Bone Shield is indicated for use for insuring three dimensional alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material.
    Device Description
    Not Found
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    K Number
    K974628
    Device Name
    FRIALIT-2 PROTECT ABUTMENT
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-03-11

    (90 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FRIALIT-2 ProTect Abutment is intended for use as a temporary abutment system for short and longer term provisionilization of the FRIALIT-2 implant system, and a provisional abutment for screw. retained crowns or bridges.
    Device Description
    Not Found
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    K Number
    K974358
    Device Name
    FRIALIT -2 SCREW
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-02-10

    (83 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous bridget.orn, to outments supporting a full arch fixed prosthesis in the totally edentulous mandibite or maxila.
    Device Description
    Not Found
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    K Number
    K974359
    Device Name
    FRIALIT-2 CYLINDER
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-02-10

    (83 days)

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

    FRIATEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
    Device Description
    Not Found
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