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510(k) Data Aggregation

    K Number
    K103790
    Device Name
    ACE TRIMARK TRICAM DENTAL IMPLANT
    Date Cleared
    2011-08-18

    (234 days)

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

    ACE SURGICAL SUPPLY COMPANY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TriMark™ TriCam™ Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients. The TriMark™ TriCam™ Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system is intended for use with all standard straight abutment prosthetics and is not intended for use with angled intents. The system can also be used for single tooth restorations. The TriMark™ TriCam™ Dental Implant System uses a two-stage implantation process and is not intended for immediate loading. The TriMark™ TriCam™ Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis™ Abutment for Nobel Replace Interface.
    Device Description
    The ACE Surgical TriMark™ TriCam™ Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Implant System (K954513) designed with technology occubilent (K023113). The ACE Surgical TriMark™ TriCam™ Dental Implant is made of Ti-6-AL-4V ELI per ASTM F136 standard and surface treated with resorbable blast media (RBM). The TriCam™ Dental Implant tapered external thread geometry is consistent with industry standard screw implant fixtures. A cover screw is included with each implant to protect the internal features of the implants are provided sterile and sterile and sterily is achieved by gamma radiation pursuant to ISO 11137.
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    K Number
    K102981
    Device Name
    ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
    Date Cleared
    2010-12-20

    (74 days)

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

    ACE SURGICAL SUPPLY COMPANY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iMARK™ Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients. The IMARK™ Internal Hexagon Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations. The IMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process. The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.
    Device Description
    The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137
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