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FDA 510(k)

Erran Dental Zirconia

K-Number: K182068 · 2018-12-13

ApplicantHangzhou Erran Technology Co., Ltd.
Decision Date2018-12-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Erran Dental Zirconia is a medical device manufactured by Hangzhou Erran Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-13 under approval number K182068. 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 Erran Dental Zirconia?

Erran Dental Zirconia is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Hangzhou Erran Technology Co., Ltd.. The 510(k) number is K182068.

When was Erran Dental Zirconia approved by the FDA?

Erran Dental Zirconia received FDA 510(k) clearance on 2018-12-13, under approval number K182068.

What company makes Erran Dental Zirconia?

Erran Dental Zirconia is manufactured by Hangzhou Erran Technology Co., Ltd..

What is the FDA product code for Erran Dental Zirconia?

The FDA product code for Erran Dental Zirconia is EIH.

Related Clinical Trials

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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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