Clearance Summary
VERTEX RAPID SIMPLIFIED received FDA 510(k) clearance under submission number K102654, sponsored by Vertex-Dental B.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-12-03.
- Submission: K102654
- Applicant / Sponsor: Vertex-Dental B.V.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2010-12-03
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.