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510(k) Data Aggregation

    K Number
    K181236
    Device Name
    HySil Impression Materials
    Manufacturer
    OSSTEM IMPLANT CO LTD
    Date Cleared
    2018-09-13

    (126 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSTEM IMPLANT CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HySil Heavy is to be used as heavy-bodied materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - Two-step impression technique using dual viscosities - Functional impressions HySil Mono is to be used as a medium-bodied tray or syringeable impression material for: - Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) - Functional impressions - Fabricating crown and bridgework or inlays - Fabricating full or partial dentures - Reline impressions - Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques - Transferring root posts when fabricating posts and cores indirectly HySil Bite is used for impression as below. - Taking occlusal surfaces - Confirming occlusal surfaces - Recording after putting the articulator
    Device Description
    HySil Impression materials are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums. HySil Heavy and HySil Mono are addition-curing, elastomeric materials with hydrophilic property, high tear strength, dimensional accuracy, and a high resistance to permanent deformation. HySil Heavy and HySil Mono are available in an assortment of delivery systems of traditional 1:1 50 ml automix cartridge (predicated, K170736) and 5:1 380 ml automix cartridge version for use in most automatic dispensing and mixing system. HySil Heavy and HySil Mono are classified into Type 1 and Type 2 according to ISO 4823 each. HySil Bite is an addition-curing silicone bite registration materials in a 50 ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated. HySil Bite is classified into jaw relation recording material according to DIN 13903.
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    K Number
    K122171
    Device Name
    MS SA IMPLANT SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO LTD
    Date Cleared
    2012-11-16

    (116 days)

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

    OSSTEM IMPLANT CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading. The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.
    Device Description
    The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS SA Implant 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. The surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching).
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    K Number
    K081786
    Device Name
    ZIOCERA & CONVERTIBLE SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO LTD
    Date Cleared
    2008-12-02

    (161 days)

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

    OSSTEM IMPLANT CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ziocera & Convertible Systems are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
    Device Description
    The Ziocera & Convertible Systems are device made of Zirconia and Titanium intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutment, Cylinder and Abutment Screw.
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    K Number
    K073247
    Device Name
    US/SS/GS SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO LTD
    Date Cleared
    2008-03-07

    (109 days)

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

    OSSTEM IMPLANT CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US/SS/GS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The US/SS/GS Fixture System is for one and two stage surgical procedures. It is not for immediate load.
    Device Description
    The US/SS/GS System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
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    K Number
    K062156
    Device Name
    SUPER ORTHODONTIC SCREW
    Manufacturer
    OSSTEM IMPLANT CO LTD
    Date Cleared
    2006-10-20

    (84 days)

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

    OSSTEM IMPLANT CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Super Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    The Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.
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