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510(k) Data Aggregation

    K Number
    K222142
    Device Name
    BR SLA Type Implant System
    Manufacturer
    Date Cleared
    2023-06-24

    (339 days)

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

    Biotem Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BR SLA Type 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. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.
    Device Description
    The BR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The 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 of the implants has been treated with S.L.A.
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    K Number
    K222144
    Device Name
    IR SLA Type Implant System
    Manufacturer
    Date Cleared
    2023-06-14

    (329 days)

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

    Biotem Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IR SLA Type 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. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.
    Device Description
    The IR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The 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 system has been treated with S.L.A.
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    K Number
    K190641
    Device Name
    AR_N SLA Type Implant System
    Manufacturer
    Date Cleared
    2020-02-21

    (345 days)

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

    Biotem Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AR N SLA Type 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. AR_N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed load.
    Device Description
    The AR_N SLA Type Implant System is a dental implant system made of CP Ti Gr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with SLA(Sandblasted with Large-grit and Acid-etching). The AR N SLA Type Implant System is offered in the following sizes. Subject implant bodies are to be used only with all abutments cleared in the primary predicate submission, and the cover screw and abutment screw to be used are the same as cleared in the primary predicate.
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    K Number
    K171297
    Device Name
    AR_N Type Implant System
    Manufacturer
    Date Cleared
    2018-01-31

    (274 days)

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

    Biotem Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AR N Type 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. AR N Type Implant System is for two stage surgical procedures. It is intended for delayed load.
    Device Description
    The AR_N Type Implant System is a dental implant system made of CP TiGr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with RBM (Resorbable Blast Media). Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.
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    K Number
    K171185
    Device Name
    IR Type Implant System
    Manufacturer
    Date Cleared
    2017-12-01

    (221 days)

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

    Biotem Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IR Type 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. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR Implant System is intended only for straight placement with no correction of angulation.
    Device Description
    IR Type Implant System is a dental implant system made of of CP Ti Gr. 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The 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 of the system has been treated with R.B.M (Resorbable Blast Media).
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