Cleared Traditional

IonoStar Plus

K160774 · Voco GmbH · Dental
Aug 2016
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K160774 is an FDA 510(k) clearance for the IonoStar Plus, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on August 3, 2016, 135 days after receiving the submission on March 21, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K160774 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2016
Decision Date August 03, 2016
Days to Decision 135 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275