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510(k) Data Aggregation

    K Number
    K181854
    Device Name
    OssBuilder System
    Manufacturer
    Osstem Implant Co., Ltd..
    Date Cleared
    2019-05-07

    (300 days)

    Product Code
    DZL, NHA
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Osstem Implant Co., Ltd..

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
    Device Description
    OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites. Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material. Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.
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    K Number
    K172354
    Device Name
    OssBuilder System
    Manufacturer
    Osstem Implant Co., Ltd..
    Date Cleared
    2018-03-26

    (235 days)

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

    Osstem Implant Co., Ltd..

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
    Device Description
    OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor. The OssBuilder System is not indicated for permanent implantation.
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    K Number
    K170736
    Device Name
    HySil Impression Materials
    Manufacturer
    Osstem Implant Co., Ltd..
    Date Cleared
    2017-06-07

    (89 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 Putty is to be used as preliminary materials for: - Two-step Putty-wash impression technique . - · One-step Putty-wash impression technique 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 Light is to be used as syringeable impression materials for: - Two-step putty-wash impression technique . - · One-step putty-wash impression technique - · Two-step impression technique using dual viscosities - · Reline impressions - · Fabricating full or partial dentures HySil Extra Light is to be used as syringeable impression materials for: - Two-step putty-wash impression technique . - · One-step putty-wash impression technique - · Two-step impression technique using dual viscosities - · Reline impressions - Fabricating full or partial dentures 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 addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars. Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml 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.
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