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FDA 510(k)

Panoura X-ERA PF/NF/MF

K-Number: K182198 · 2019-01-31

ApplicantThe Yoshida Dental Mfg. Co., Ltd.
Decision Date2019-01-31
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Panoura X-ERA PF/NF/MF is a medical device manufactured by The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under approval number K182198. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panoura X-ERA PF/NF/MF?

Panoura X-ERA PF/NF/MF is a medical device that received FDA 510(k) clearance on 2019-01-31. It is manufactured by The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K182198.

When was Panoura X-ERA PF/NF/MF approved by the FDA?

Panoura X-ERA PF/NF/MF received FDA 510(k) clearance on 2019-01-31, under approval number K182198.

What company makes Panoura X-ERA PF/NF/MF?

Panoura X-ERA PF/NF/MF is manufactured by The Yoshida Dental Mfg. Co., Ltd..

What is the FDA product code for Panoura X-ERA PF/NF/MF?

The FDA product code for Panoura X-ERA PF/NF/MF is MUH.

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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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