510(k) DEN230035

DentalMonitoring by Dental Monitoring Sas — Product Code SBC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 17, 2024
Date Received: May 4, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dental Image Analyzer
Device Class: Class II
Regulation Number: 872.1770
Review Panel: DE
Submission Type

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.