Flexible Block
K-Number: K213994 · 2022-03-04
Decision Date2022-03-04
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Flexible Block is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2022-03-04 under approval number K213994. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flexible Block?
Flexible Block is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K213994.
When was Flexible Block approved by the FDA?
Flexible Block received FDA 510(k) clearance on 2022-03-04, under approval number K213994.
What company makes Flexible Block?
Flexible Block is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for Flexible Block?
The FDA product code for Flexible Block is EBI.
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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.