HCG Zirconia Ceramic Block
K-Number: K193090 · 2020-10-29
ApplicantHocheng Corporation
Decision Date2020-10-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HCG Zirconia Ceramic Block is a medical device manufactured by Hocheng Corporation. It received FDA 510(k) clearance on 2020-10-29 under approval number K193090. 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 HCG Zirconia Ceramic Block?
HCG Zirconia Ceramic Block is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Hocheng Corporation. The 510(k) number is K193090.
When was HCG Zirconia Ceramic Block approved by the FDA?
HCG Zirconia Ceramic Block received FDA 510(k) clearance on 2020-10-29, under approval number K193090.
What company makes HCG Zirconia Ceramic Block?
HCG Zirconia Ceramic Block is manufactured by Hocheng Corporation.
What is the FDA product code for HCG Zirconia Ceramic Block?
The FDA product code for HCG Zirconia Ceramic Block 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.