Dental

DentalMonitoring

Dental Monitoring SAS

FDA-cleared AI medical device

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.

FDA Submission Metadata

Submission number
DEN230035
Decision date
May 2024
FDA panel
Dental
Product code
SBC
Clinical task (npj)
diagnosis
Data modality (npj)
Images

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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