Clearance Summary
ZENOFLEX DIMENSION received FDA 510(k) clearance under submission number K103773, sponsored by Wieland Dental + Technik GmbH & Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-03-16.
- Submission: K103773
- Applicant / Sponsor: Wieland Dental + Technik GmbH & Co. KG
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2011-03-16
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.