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510(k) Data Aggregation

    K Number
    K222636
    Device Name
    ET Abutment System
    Manufacturer
    Hiossen Inc.
    Date Cleared
    2023-04-28

    (240 days)

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

    Hiossen Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
    Device Description
    The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
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    K Number
    K170421
    Device Name
    ET Hybrid Abutment
    Manufacturer
    Hiossen Inc.
    Date Cleared
    2018-01-11

    (332 days)

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

    Hiossen Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
    Device Description
    ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured and bonded into the ET Link Abutment by Hiossen only with design input using CAD software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics.
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    K Number
    K162390
    Device Name
    ET Hybrid Abutment
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2017-01-30

    (157 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
    Device Description
    ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured by Hiossen only with design input using CAD/CAM software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.
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    K Number
    K153332
    Device Name
    ETIII SA Fixture System (O3.2mm)
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2016-10-27

    (343 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETIII SA Fixture System (03.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
    Device Description
    The ETIII SA Fixture System (Ø3.2) 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 ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
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    K Number
    K151542
    Device Name
    A-Oss
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2016-08-03

    (422 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas. - Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction - Filling in the missing part of a bone surrounding an implant - Maxillary sinus lift for implant - Alveolar bone augmentation/restoration
    Device Description
    Bone Grafting Material
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    K Number
    K151626
    Device Name
    ET III Bio-SA Fixture System
    Manufacturer
    HiOSSEN Inc.
    Date Cleared
    2016-07-21

    (400 days)

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

    HiOSSEN Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETIII Bio-SA Fixture 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 ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.
    Device Description
    ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).
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    K Number
    K140934
    Device Name
    HIOSSEN IMPLANT SYSTEM
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2014-11-12

    (215 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HIOSSEN 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.
    Device Description
    The HIOSSEN 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 HIOSSEN Implant System include length 18mm implant. The HIOSSEN Implant System is a revised product that Dimension and code(art#) are changed and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide Fixture therefore there is no difference about material, indication for use and design from predicate as above. And the subject devices and the predicate devices encompass the same range of physical dimensions except length 18mm and characteristics, including implant diameter and surface treatment.
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    K Number
    K132067
    Device Name
    MULTI ANGLED ABUTMENT SYSTEM
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2013-12-20

    (170 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
    Device Description
    The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096. The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier. Carrier is just to carry the Multi Angled Abutment to implanted Fixture.
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    K Number
    K123471
    Device Name
    ETII SA FIXTURE SYSTEM
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2013-07-05

    (234 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETII SA Fixture 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
    Device Description
    The ETII SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures. ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847). The ETII SA Fixture 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 ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.
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    K Number
    K123627
    Device Name
    ET SMARTFIT ABUTMENT
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2013-06-28

    (217 days)

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

    HIOSSEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
    Device Description
    The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory. The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.
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