Cleared Traditional

IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID

K151142 · Wieland Dental + Technik GmbH & Co. KG · Dental
Aug 2015
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K151142 is an FDA 510(k) clearance for the IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on August 13, 2015, 106 days after receiving the submission on April 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K151142 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2015
Decision Date August 13, 2015
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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