Clearance Summary
DentalMonitoring received FDA 510(k) clearance under submission number DEN230035, sponsored by Dental Monitoring Sas. The device was reviewed via the Direct premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-05-17.
- Submission: DEN230035
- Applicant / Sponsor: Dental Monitoring Sas
- Clearance pathway: Direct
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1770
- Decision date: 2024-05-17
Classification & Regulation
This clearance is catalogued under FDA product code SBC and 21 CFR 872.1770, within the Dental review panel as a Class II device.