FDA Product Code SBC: Dental Image Analyzer
A Dental Image Analyzer Is A Prescription Home Use Device That Uses Software Intended To Collect And Analyze Patient-specific, Optical Camera-based, Intraoral Images. The Analyses Are Provided To Dental Health Care Professionals As An Aid To Diagnosis Of Oral Health Conditions And/or To Monitor Treatment Progress.
Leading manufacturers include Dental Monitoring Sas.
FDA 510(k) Cleared Dental Image Analyzer Devices (Product Code SBC)
About Product Code SBC - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBC since 2024, with 0 receiving FDA clearance (average review time: 379 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
SBC devices are reviewed by the Dental panel. Browse all Dental devices →