FDA 510(k)

VITA ENAMIC Implant Solutions (IS)

K-Number: K153645 · 2016-06-30

ApplicantVita Zahnfabrik H.Rauter GmbH Co.

Decision Date2016-06-30

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

VITA ENAMIC Implant Solutions (IS) is a medical device manufactured by Vita Zahnfabrik H.Rauter GmbH Co.. It received FDA 510(k) clearance on 2016-06-30 under approval number K153645. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITA ENAMIC Implant Solutions (IS)?

VITA ENAMIC Implant Solutions (IS) is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Vita Zahnfabrik H.Rauter GmbH Co.. The 510(k) number is K153645.

When was VITA ENAMIC Implant Solutions (IS) approved by the FDA?

VITA ENAMIC Implant Solutions (IS) received FDA 510(k) clearance on 2016-06-30, under approval number K153645.

What company makes VITA ENAMIC Implant Solutions (IS)?

VITA ENAMIC Implant Solutions (IS) is manufactured by Vita Zahnfabrik H.Rauter GmbH Co..

What is the FDA product code for VITA ENAMIC Implant Solutions (IS)?

The FDA product code for VITA ENAMIC Implant Solutions (IS) is NHA.

Other Devices by Vita Zahnfabrik H.Rauter GmbH Co.

K180703VITA YZ ST and VITA YZ XT

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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.