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FDA 510(k)

ESTETICA Dental Treatment Unit and Accessories

K-Number: K161488 · 2016-12-08

ApplicantKaltenbach & Voigt GmbH
Decision Date2016-12-08
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTETICA Dental Treatment Unit and Accessories is a medical device manufactured by Kaltenbach & Voigt GmbH. It received FDA 510(k) clearance on 2016-12-08 under approval number K161488. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTETICA Dental Treatment Unit and Accessories?

ESTETICA Dental Treatment Unit and Accessories is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Kaltenbach & Voigt GmbH. The 510(k) number is K161488.

When was ESTETICA Dental Treatment Unit and Accessories approved by the FDA?

ESTETICA Dental Treatment Unit and Accessories received FDA 510(k) clearance on 2016-12-08, under approval number K161488.

What company makes ESTETICA Dental Treatment Unit and Accessories?

ESTETICA Dental Treatment Unit and Accessories is manufactured by Kaltenbach & Voigt GmbH.

What is the FDA product code for ESTETICA Dental Treatment Unit and Accessories?

The FDA product code for ESTETICA Dental Treatment Unit and Accessories is EIA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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