Cleared Special

ZENO ZR DISC

K073108 · Wieland Dental + Technik GmbH & Co. KG · Dental
Nov 2007
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K073108 is an FDA 510(k) clearance for the ZENO ZR DISC, 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 November 21, 2007, 19 days after receiving the submission on November 2, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K073108 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2007
Decision Date November 21, 2007
Days to Decision 19 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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