510(k) DEN230035
DEN230035 is an FDA 510(k) premarket notification submitted by Dental Monitoring Sas for the device "DentalMonitoring". The FDA issued a decision of De Novo Granted on May 17, 2024. The device falls under product code SBC (Dental Image Analyzer), a Class II device regulated under 21 CFR 872.1770.
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.