Shofu Block HC Hard
K-Number: K200470 · 2021-02-05
ApplicantShofu Dental Corporation
Decision Date2021-02-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Shofu Block HC Hard is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2021-02-05 under approval number K200470. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Shofu Block HC Hard?
Shofu Block HC Hard is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Shofu Dental Corporation. The 510(k) number is K200470.
When was Shofu Block HC Hard approved by the FDA?
Shofu Block HC Hard received FDA 510(k) clearance on 2021-02-05, under approval number K200470.
What company makes Shofu Block HC Hard?
Shofu Block HC Hard is manufactured by Shofu Dental Corporation.
What is the FDA product code for Shofu Block HC Hard?
The FDA product code for Shofu Block HC Hard is EBF.
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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.