Clearance Summary
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR received FDA 510(k) clearance under submission number K112710, sponsored by Wieland Dental + Technik 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 2011-10-17.
- Submission: K112710
- Applicant / Sponsor: Wieland Dental + Technik GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2011-10-17
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.