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510(k) Data Aggregation

    K Number
    K242103
    Device Name
    TRIOS Ready Tip
    Manufacturer
    3Shape TRIOS A/S
    Date Cleared
    2025-04-04

    (260 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    3Shape TRIOS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
    Device Description
    The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth. The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and data transmission from the scanner is handled by the TRIOS module software, which holds the interface to the user. The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries. The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D data collected by combining blue and white light in turn. 3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).
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    K Number
    K221249
    Device Name
    L1P-1F (TRIOS 5)
    Manufacturer
    3Shape TRIOS A/S
    Date Cleared
    2022-09-16

    (137 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    3Shape TRIOS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
    Device Description
    The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth. The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user. The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries. The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.
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