Cleared Traditional

ZENO PMMA DISC

K080182 · Wieland Dental + Technik GmbH & Co. KG · Dental
Apr 2008
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K080182 is an FDA 510(k) clearance for the ZENO PMMA DISC, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on April 8, 2008, 74 days after receiving the submission on January 25, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K080182 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2008
Decision Date April 08, 2008
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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