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510(k) Data Aggregation

    K Number
    K172821
    Device Name
    Ti-one 101 TS Dental Implant System
    Date Cleared
    2018-06-11

    (266 days)

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

    Hung Chun Bio-S Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Intended for delayed loading.
    Device Description
    - (1) This Product is designed to be used in dental surgery in mandible or maxilla-arch, where has missing teeth, to have dental crown, fixation-bridge, over-denture installed afterwards, and to support and restore patient's chewing function. - (2) This implant (Ti-one 101 TS dental implants (Fixture)) is made of grade 4 pure titanium, featuring sandblasting + acid etching surface treatment (SLAffinity). - (3) Healing screw is one-piece abutment made of grade 4 titanium. - (4) Abutment is two-piece abutment made of grade 4 titanium. Its surface was anodized. - (5) Label attached to the surface of outer packaging indicates specification and model number. The range of diameter for implant (fixture) is provided as below: Ø Diameter: 3.5, 4.0, 4.5, 5.0 mm Length: 7.0, 8.0, 9.5, 11.0, 12.5, 14.0 mm All diameters are available in all lengths, other than the 3.5mm diameter which is not available in the 7.0mm length. The range of diameters and angulations for each screw model and abutment model are provided as below: Healing Screw: Ø 4.3 mm, G/H 1.0, 3.0, 4.0 mm, Height (H) 3.5, 5.0, 7.0 mm Angled Abutment: Ø 4.5, 5.5 mm, G/H 3.5 mm, V/H 11.0 mm, Length (L) 14.13, 14.15, 14.20 mm, Angulation range 12.5°, 20.0°, 27.5°
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