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510(k) Data Aggregation

    K Number
    K212364
    Device Name
    BLT Dental Implant System
    Date Cleared
    2022-08-10

    (376 days)

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

    Bio Concept Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
    Device Description
    The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.
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    K Number
    K192274
    Device Name
    BV Dental Implant System
    Date Cleared
    2020-06-18

    (301 days)

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

    Bio Concept Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BV 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
    Device Description
    The proposed devices, dental implant system consists of dental implants, abutments and healing cap, it is used in one or two-stage dental implant placement and restoration. The dental implants are available in Mini and Regular two types. The implant is made from titanium and the surface of the implants are treated with Sandblasting and Acid etching. The implants are provided in lengths from 7.0-15.0 and in diameter from 3.7 to 6.8. The abutments in this submission include transfer abutment, temporary abutment, multi abutment, multi angled abutment, equator abutment and Esthetic-low Temporary Cylinder. The abutment is also available in mini and regular two types to match with the corresponding implant. The abutment is made from titanium alloy. The healing cap in this submission include cover screw, healing abutment and equator healing abutment.
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    K Number
    K150388
    Device Name
    Dental Implant System
    Date Cleared
    2015-11-12

    (267 days)

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

    BIO CONCEPT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
    Device Description
    The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices. The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments. Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment. Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.
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