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FDA 510(k)

Dental Zirconia Blocks

K-Number: K192262 · 2020-05-29

Decision Date2020-05-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Zirconia Blocks is a medical device manufactured by De Corematrix Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under approval number K192262. 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 Zirconia Blocks?

Dental Zirconia Blocks is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by De Corematrix Co., Ltd.. The 510(k) number is K192262.

When was Dental Zirconia Blocks approved by the FDA?

Dental Zirconia Blocks received FDA 510(k) clearance on 2020-05-29, under approval number K192262.

What company makes Dental Zirconia Blocks?

Dental Zirconia Blocks is manufactured by De Corematrix Co., Ltd..

What is the FDA product code for Dental Zirconia Blocks?

The FDA product code for Dental Zirconia Blocks 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.