Cleared Traditional

INTEGO Family and Accesories

K150909 · Sirona Dental Systems GmbH · Dental
Jul 2015
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K150909 is an FDA 510(k) clearance for the INTEGO Family and Accesories, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on July 17, 2015, 105 days after receiving the submission on April 3, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K150909 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2015
Decision Date July 17, 2015
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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