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510(k) Data Aggregation

    K Number
    K231210
    Device Name
    DGA Abutment
    Date Cleared
    2024-03-05

    (313 days)

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

    Modern Dental Laboratory (DG) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for: a. For fixing into the endosseous implant. b. For dental laboratory use during fabrication of restoration. The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).
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    K Number
    K231884
    Device Name
    TRIOCLEAR System
    Date Cleared
    2023-09-01

    (66 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Dental Laboratory (DG) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.
    Device Description
    The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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