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FDA 510(k)

Vintage Prime Press

K-Number: K212939 · 2022-03-18

ApplicantShofu Dental Corporation
Decision Date2022-03-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vintage Prime Press 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 2022-03-18 under 510(k) number K212939. 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 Prime Press?

Vintage Prime Press is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Shofu Dental Corporation. The 510(k) number is K212939.

When did Vintage Prime Press receive FDA 510(k) clearance?

Vintage Prime Press received FDA 510(k) clearance on 2022-03-18, under 510(k) number K212939.

Who is the listed applicant for Vintage Prime Press?

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 Prime Press?

The FDA product code for Vintage Prime Press is EIH.

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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.

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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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