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510(k) Data Aggregation

    K Number
    K192294
    Device Name
    I Do
    Manufacturer
    I Do Biotech Co., Ltd
    Date Cleared
    2020-07-31

    (343 days)

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

    I Do Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I Do 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. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
    Device Description
    The I Do Fixtures consist of two types of fixtures, Fixture-MT ACTIVE. Both fixtures are a thread type implant made of Ti CP4 according to ASTM F67 which will be placed in the alveola bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixtures' surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Fixture-S and Fixture MT-Active have same connection but different design. Fixture S has 2 type of screw bite 0.45mm and 0.35mm in coronal part. Fixture MT-ACTIVE has use only one screw bite of 0.59mm is more tapered. | Device Component | Diameters (Ø) | Lengths (mm) | |-------------------|---------------|-----------------------------| | Fixture-S | 3.8 | 8.5/10.0/11.5/13.0/15.0 | | | 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 5.5 | 7.3/8.5/10.0/11.5/ | | | 6.0 | 7.3/8.5/10.0 | | | 7.0 | 7.3/8.5/10.0 | | Fixture-MT ACTIVE | 3.8 | 8.5/10.0/11.5/13.0/15.0 | | | 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | | | 5.5 | 7.3/8.5/10.0/11.5/ | | | 6.0 | 7.3/8.5/10.0 | | | 7.0 | 7.3/8.5/10.0 | Tolerance of dimension shall be within ± 1% range. I Do fixtures are provided sterilized.
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