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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 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 2016-06-30 under 510(k) 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. The listed applicant is Vita Zahnfabrik H.Rauter GmbH Co.. The 510(k) number is K153645.

When did VITA ENAMIC Implant Solutions (IS) receive FDA 510(k) clearance?

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

Who is the listed applicant for VITA ENAMIC Implant Solutions (IS)?

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 ENAMIC Implant Solutions (IS)?

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

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

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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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