Clearance Summary
VITA VM LC Flow received FDA 510(k) clearance under submission number K152373, 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 2015-12-30.
- Submission: K152373
- Applicant / Sponsor: Vita Zahnfabrik H.Rauter GmbH & Co.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2015-12-30
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.