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510(k) Data Aggregation

    K Number
    K090397
    Device Name
    XPI ANGLED ABUTMENTS
    Manufacturer
    KEYSTONE DENTAL, INC.
    Date Cleared
    2009-06-05

    (108 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEYSTONE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.
    Device Description
    The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load. The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant. The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications. The device is provided non-sterile to the user in medical grade packaging.
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    K Number
    K071070
    Device Name
    OLYMPUS DENTAL IMPLANT SYSTEM
    Manufacturer
    KEYSTONE DENTAL, INC.
    Date Cleared
    2007-10-23

    (190 days)

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

    KEYSTONE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Dental Implant System is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability.
    Device Description
    The Olympus Dental Implant System includes various sizes of parallel sided, threaded, root-form dental implants and straight abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stobility is reached according to the Instructions for Use, Olympus Dental Implants with an insertion depth of 8 mm or more may be immediately loaded. The system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components (Class 1 exempt, not a subject of this submission) intended to facilitate the prevaration of prosthetic restorations.
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    K Number
    K071599
    Device Name
    EASYGUIDE
    Manufacturer
    KEYSTONE DENTAL, INC.
    Date Cleared
    2007-07-11

    (30 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEYSTONE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyGuide is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the EasyGuide treatment planning software.
    Device Description
    Not Found
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