FDA 510(k)

KaVo DEXIS CariVu 3-in-1

K号: K182712 · 2019-11-23

决定日期2019-11-23

产品代码NTK

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决定实质等同

器械摘要

DEXIS CariVu 3-in-1 by KaVo 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 2019-11-23 under 510(k) number K182712. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DEXIS CariVu 3-in-1 by KaVo?

DEXIS CariVu 3-in-1 by KaVo is a medical device that received FDA 510(k) clearance on 2019-11-23. The listed applicant is Kaltenbach & Voigt GmbH. The 510(k) number is K182712.

When did DEXIS CariVu 3-in-1 by KaVo receive FDA 510(k) clearance?

DEXIS CariVu 3-in-1 by KaVo received FDA 510(k) clearance on 2019-11-23, under 510(k) number K182712.

Who is the listed applicant for DEXIS CariVu 3-in-1 by KaVo?

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 DEXIS CariVu 3-in-1 by KaVo?

The FDA product code for DEXIS CariVu 3-in-1 by KaVo is NTK.

列明Kaltenbach & Voigt GmbH为申报人的其他记录

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K181110PROPHYflex 4 K163239SMARTmatic K161488ESTETICA 牙科治疗单元和附件

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