Clearance Summary
NextDent Denture 3D+ received FDA 510(k) clearance under submission number K191497, sponsored by Vertex-Dental B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-11-01.
- Submission: K191497
- Applicant / Sponsor: Vertex-Dental B.V.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2019-11-01
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.