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510(k) Data Aggregation
K Number
K242103Device Name
TRIOS Ready Tip
Manufacturer
3Shape TRIOS A/S
Date Cleared
2025-04-04
(260 days)
Product Code
NBL
Regulation Number
872.1745Why 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
K221249Device Name
L1P-1F (TRIOS 5)
Manufacturer
3Shape TRIOS A/S
Date Cleared
2022-09-16
(137 days)
Product Code
NBL
Regulation Number
872.1745Why 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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