Dental Zirconia Pre-shaded Block
K-Number: K214003 · 2022-02-18
Decision Date2022-02-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dental Zirconia Pre-shaded Block is a medical device manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K214003. 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 Pre-shaded Block?
Dental Zirconia Pre-shaded Block is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd.. The 510(k) number is K214003.
When was Dental Zirconia Pre-shaded Block approved by the FDA?
Dental Zirconia Pre-shaded Block received FDA 510(k) clearance on 2022-02-18, under approval number K214003.
What company makes Dental Zirconia Pre-shaded Block?
Dental Zirconia Pre-shaded Block is manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd..
What is the FDA product code for Dental Zirconia Pre-shaded Block?
The FDA product code for Dental Zirconia Pre-shaded 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.