Clearance Summary
VITA VMK MASTER received FDA 510(k) clearance under submission number K093446, sponsored by Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-12-03.
- Submission: K093446
- Applicant / Sponsor: Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2009-12-03
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.