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FDA 510(k)

VITA YZ ST and VITA YZ XT

K-Number: K180703 · 2018-08-01

ApplicantVita Zahnfabrik H.Rauter GmbH Co.
Decision Date2018-08-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA YZ ST and VITA YZ XT is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik H.Rauter GmbH Co.. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K180703. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITA YZ ST and VITA YZ XT?

VITA YZ ST and VITA YZ XT is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Vita Zahnfabrik H.Rauter GmbH Co.. The 510(k) number is K180703.

When did VITA YZ ST and VITA YZ XT receive FDA 510(k) clearance?

VITA YZ ST and VITA YZ XT received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180703.

Who is the listed applicant for VITA YZ ST and VITA YZ XT?

The FDA 510(k) record lists Vita Zahnfabrik H.Rauter GmbH Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA YZ ST and VITA YZ XT?

The FDA product code for VITA YZ ST and VITA YZ XT is EIH.

Other records listing Vita Zahnfabrik H.Rauter GmbH Co. 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.

K243940VITA YZ Multi TranslucentK153645VITA ENAMIC Implant Solutions (IS)

Related Devices (Code: EIH)

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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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