Clearance Summary
ENAMIC received FDA 510(k) clearance under submission number K122269, 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 2012-12-13.
- Submission: K122269
- Applicant / Sponsor: Vita Zahnfabrik H.Rauter GmbH & Co.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2012-12-13
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.