Clearance Summary
VITA Ambria received FDA 510(k) clearance under submission number K193436, sponsored by Vita Zahnfabrik GmbH H Rauter & CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-05-14.
- Submission: K193436
- Applicant / Sponsor: Vita Zahnfabrik GmbH H Rauter & CO
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2020-05-14
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.