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FDA 510(k)

Dental Ceramic

K-Number: K182350 · 2019-05-22

Decision Date2019-05-22
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Ceramic is a medical device manufactured by Baot Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under approval number K182350. 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 Dental Ceramic?

Dental Ceramic is a medical device that received FDA 510(k) clearance on 2019-05-22. It is manufactured by Baot Biological Technology Co., Ltd.. The 510(k) number is K182350.

When was Dental Ceramic approved by the FDA?

Dental Ceramic received FDA 510(k) clearance on 2019-05-22, under approval number K182350.

What company makes Dental Ceramic?

Dental Ceramic is manufactured by Baot Biological Technology Co., Ltd..

What is the FDA product code for Dental Ceramic?

The FDA product code for Dental Ceramic is EIH.

Related Clinical Trials

Related Devices (Code: EIH)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.