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510(k) Data Aggregation

    K Number
    K241127
    Device Name
    INNO SLA Mini Plus® Implant System
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2024-12-27

    (248 days)

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

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INNO SLA Mini Plus® Implant System is divided into two types: - Cemented Type The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors to serve as temporary support prosthetic devices during stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients. - Ball Type The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exeed one hundred and eighty (180) days. The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.
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    K Number
    K231411
    Device Name
    INNO SLA Submerged Hybrid Ti-Base System
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-12-20

    (218 days)

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

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.
    Device Description
    INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems: INNO SLA Submerged Implant System(k132242) by Cowellmedi Co., Ltd. The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture. Hybrid S Ti-Base, Hybrid L Ti-Base, Hybrid A Ti-Base.
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    K Number
    K232546
    Device Name
    Meta G UCLA Abutment
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-11-21

    (90 days)

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

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Meta G UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
    Device Description
    The Meta G UCLA Abutment is used for prosthetic restoration. The Meta G UCLA Abutment consists of Meta G UCLA Abutment and abutment screws. The Meta G UCLA Abutment is made of CCM (ASTM F1537) and POM (ASTM F1855). The casting material to make prosthesis is also CCM. When cast a prosthesis with the Meta G UCLA Abutment, the post height above the transmucosal collar of the Meta G UCLA Abutment has to be taller than 4mm and maximum 7mm. The Meta G UCLA Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. No angulation is to be incorporated into the cast final device and abutments should not be used on implants placed at an angle. It is provided non-sterile, this should be user steam sterilized before use. The Meta G UCLA abutment is compatible with our own implant system. - INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. - INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd. The design envelope for the Meta G UCLA Abutment is as follows. <Design limits - Meta G UCLA Abutment> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.8mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm <Design limits - Meta G UCLA Abutment (Narrow)> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.93mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm
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    K Number
    K231395
    Device Name
    INNO SLA Submerged Narrow Implant System
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-10-18

    (156 days)

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

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.
    Device Description
    The INNO SLA Submerged Implant System offers the following components. 1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm 2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm 3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm 4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm 5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm 6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°) 7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm 8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type 9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm 10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm Ø 1.95 x 9.3 mm 12 Multi Cylinder Screw Ø 2.25 x 5 mm 13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm 14 Temporary Abutment Ø 4.5 x 10 mm 15 Multi Titanium Cylinder Ø 4.5 x 9 mm
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    K Number
    K211554
    Device Name
    InnoGenic Non-resorbable Membrane
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-02-24

    (646 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnoGenic™ Non-resorbable membrane is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.
    Device Description
    Not Found
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    K Number
    K201323
    Device Name
    INNO SLA Submerged Implant System
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2022-01-25

    (617 days)

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

    Cowellmedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INNO SLA Submerged 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, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
    Device Description
    The INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.
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