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510(k) Data Aggregation

    K Number
    K142313
    Device Name
    OneQ-SL Implant System
    Manufacturer
    DENTIS CO. LTD.
    Date Cleared
    2015-12-10

    (478 days)

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

    DENTIS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneQ-SL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
    Device Description
    The OneQ-SL Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The OneQ-SL Implant system includes the i-Clean OneQ Fixtures which are Internal Octa-connected, non-submerged fixtures. The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.
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    K Number
    K082843
    Device Name
    MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
    Manufacturer
    DENTIS CO. LTD.
    Date Cleared
    2009-06-19

    (263 days)

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

    DENTIS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region.
    Device Description
    The Dentis Dental Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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    K Number
    K083586
    Device Name
    I-FIX SYSTEM
    Manufacturer
    DENTIS CO. LTD.
    Date Cleared
    2009-04-29

    (146 days)

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

    DENTIS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
    Device Description
    The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).
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    K Number
    K073486
    Device Name
    DENTIS DENTAL IMPLANT SYSTEM
    Manufacturer
    DENTIS CO. LTD.
    Date Cleared
    2008-04-04

    (114 days)

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

    DENTIS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentis Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
    Device Description
    The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine
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