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FDA 510(k)

DEXIS CariVu 3-in-1 by KaVo

K-Number: K182712 · 2019-11-23

ApplicantKaltenbach & Voigt GmbH
Decision Date2019-11-23
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K181110PROPHYflex 4K163239SMARTmaticK161488ESTETICA Dental Treatment Unit and Accessories

Related Devices (Code: NTK)

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.

K261847iTero Lumina™ ProAlign Technology , Ltd.K250771Primescan 2Dentsply Sirona, Inc.K240573iTero Lumina™ ProAlign Technology , Ltd.K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLCK193659iTero Element 5DAlign Technology, Inc.K172007CamX Triton HD Proxi HeadDuerr Dental AG

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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