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510(k) Data Aggregation
K Number
K242437Device Name
Smile Dx®
Manufacturer
Cube Click, Inc.
Date Cleared
2025-05-14
(271 days)
Product Code
MYN, LLZ
Regulation Number
892.2070Why did this record match?
Applicant Name (Manufacturer) :
Cube Click, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy.
Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of mesial and distal bone levels associated with each tooth.
The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment.
Smile Dx® supports both digital and phosphor sensors.
Device Description
Smile Dx® is a computer assisted detection (CADe) device indicated for use by licensed dentists as an aid in their assessment of bitewing and periapical radiographs of secondary dentition in adult patients. Smile Dx® utilizes machine learning to produce annotations for the following findings:
- Caries
- Periapical radiolucencies
- Bone level measurements (mesial and distal)
- Normal anatomy (enamel, dentin, pulp, and bone)
- Restorations
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