Cleared Traditional

ESTETICA Dental Treatment Unit and Accessories

K161488 · Kaltenbach & Voigt GmbH · Dental
Dec 2016
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K161488 is an FDA 510(k) clearance for the ESTETICA Dental Treatment Unit and Accessories, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on December 8, 2016, 190 days after receiving the submission on June 1, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K161488 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2016
Decision Date December 08, 2016
Days to Decision 190 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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