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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 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.

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. 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.

Other records listing Kaltenbach & Voigt GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182712DEXIS CariVu 3-in-1 by KaVoK181110PROPHYflex 4K163239SMARTmatic

Related Devices (Code: EIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLCK242404BDC Dental UnitBdc Dental Corporation , Ltd.

Official Source

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

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