Clearance Summary
Provecta 3D Prime and Provecta 3D Prime Ceph received FDA 510(k) clearance under submission number K232487, sponsored by Durr Dental SE. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-09-14.
- Submission: K232487
- Applicant / Sponsor: Durr Dental SE
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2023-09-14
Classification & Regulation
This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.