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FDA 510(k)

VINTAGE PRO

K-Number: K181496 · 2018-12-18

ApplicantShofu Dental Corporation
Decision Date2018-12-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VINTAGE PRO 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 2018-12-18 under 510(k) number K181496. 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 PRO?

VINTAGE PRO is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Shofu Dental Corporation. The 510(k) number is K181496.

When did VINTAGE PRO receive FDA 510(k) clearance?

VINTAGE PRO received FDA 510(k) clearance on 2018-12-18, under 510(k) number K181496.

Who is the listed applicant for VINTAGE PRO?

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 PRO?

The FDA product code for VINTAGE PRO is EIH.

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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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