FDA 510(k)

ESTETICA 牙科治疗单元和附件

K号: K161488 · 2016-12-08

决定日期2016-12-08

产品代码EIA

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Kaltenbach & Voigt GmbH. The 510(k) number is K161488.

When did ESTETICA Dental Treatment Unit and Accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for ESTETICA Dental Treatment Unit and Accessories?

The FDA 510(k) record lists Kaltenbach & Voigt GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

列明Kaltenbach & Voigt GmbH为申报人的其他记录

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