Cleared Special

ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR

K112710 · Wieland Dental + Technik GmbH & Co. KG · Dental

Oct 2011

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K112710 is an FDA 510(k) clearance for the ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on October 17, 2011, 28 days after receiving the submission on September 19, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K112710 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2011
Decision Date	October 17, 2011
Days to Decision	28 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF