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FDA 510(k)

Vintage Art Universal

K-Number: K191794 · 2019-10-03

ApplicantShofu Dental Corporation
Decision Date2019-10-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vintage Art Universal is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K191794. 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 Vintage Art Universal?

Vintage Art Universal is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Shofu Dental Corporation. The 510(k) number is K191794.

When did Vintage Art Universal receive FDA 510(k) clearance?

Vintage Art Universal received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191794.

Who is the listed applicant for Vintage Art Universal?

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

What is the FDA product code for Vintage Art Universal?

The FDA product code for Vintage Art Universal is EIH.

Other records listing Shofu Dental Corporation as applicant

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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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