Clearance Summary
VITA ENAMIC Implant Solutions (IS) received FDA 510(k) clearance under submission number K153645, sponsored by Vita Zahnfabrik H.Rauter GmbH Co.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-06-30.
- Submission: K153645
- Applicant / Sponsor: Vita Zahnfabrik H.Rauter GmbH Co.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2016-06-30
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.