Cleared Traditional

K071548 - WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
(FDA 510(k) Clearance)

K071548 · Merz Dental GmbH · Dental

Aug 2007

Decision

76d

Days

Class 2

Risk

K071548 is an FDA 510(k) clearance for the WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on August 21, 2007, 76 days after receiving the submission on June 6, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K071548 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2007
Decision Date	August 21, 2007
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF