ESTETICA Dental Treatment Unit and Accessories— 510(k) K161488

Name: FDA 510(k) clearance K161488
Creator: U.S. Food and Drug Administration
Published: 2016-12-08

Substantially Equivalent

Kaltenbach & Voigt GmbH

FDA 510(k) clearance K161488 for ESTETICA Dental Treatment Unit and Accessories, Substantially Equivalent on 2016-12-08. Applicant: Kaltenbach & Voigt GmbH. Device class: 1.

Clearance details

Applicant: Kaltenbach & Voigt GmbH
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2016-06-01
Decision date: 2016-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Biberach, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.