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FDA 510(k)

AMARIS GINGIVA OPAQUER

K-Number: K090843 · 2009-06-17

ApplicantVoco GmbH
Decision Date2009-06-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMARIS GINGIVA OPAQUER is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2009-06-17 under 510(k) number K090843. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMARIS GINGIVA OPAQUER?

AMARIS GINGIVA OPAQUER is a medical device that received FDA 510(k) clearance on 2009-06-17. The listed applicant is Voco GmbH. The 510(k) number is K090843.

When did AMARIS GINGIVA OPAQUER receive FDA 510(k) clearance?

AMARIS GINGIVA OPAQUER received FDA 510(k) clearance on 2009-06-17, under 510(k) number K090843.

Who is the listed applicant for AMARIS GINGIVA OPAQUER?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMARIS GINGIVA OPAQUER?

The FDA product code for AMARIS GINGIVA OPAQUER is EBF.

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Other records listing Voco GmbH as applicant

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Related Devices (Code: EBF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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