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510(k) Data Aggregation
K Number
K222054Device Name
Denti.AI Auto-Chart
Manufacturer
Denti.AI Technology Inc.
Date Cleared
2022-11-22
(133 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Denti.AI Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Denti. Al Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals (Users), comprising general dental specialists, and dental hygienists, in detecting dental structures and producing dental charting data based on the interpretation of intraoral and extraoral 2D X-Ray images.
Denti.AI Auto-Chart is intended to assist in:
· Detecting natural dental structures: teeth and missing teeth
· Detecting dental structures added through past restment: implants, crowns, pontics, endodonic treatment, fillings
· Choosing treatment options
• Producing dental charts based on image analysis results as well as conditions added manually or produced by integrated CAD devices
The device is aimed to be used with images from the adult population only (≥22 years old and do not have remaining primary teeth). The device is not intended as a replacement for a complete clinical judgment that considers other relevant information from the image or patient history.
Device Description
Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on the interpretation of 2D X-Ray images. The device is intended to assist dental professionals in detecting teeth and missing teeth, numbering teeth, and detecting dental structures added through past restorative treatment, including implants, crowns, pontics, endodontic treatment, and fillings.
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