Cleared Abbreviated

K130184 - ZENOLUX
(FDA 510(k) Clearance)

K130184 · Wieland Dental + Technik GmbH & Co. KG · Dental

May 2013

Decision

119d

Days

Class 2

Risk

K130184 is an FDA 510(k) clearance for the ZENOLUX. This device is classified as 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 May 24, 2013, 119 days after receiving the submission on January 25, 2013.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K130184 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2013
Decision Date	May 24, 2013
Days to Decision	119 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF