Renamel® Microhybrid ;Renamel® Flowable Microhybrid
K-Number: K222435 · 2022-10-11
ApplicantCosmedent, Inc.
Decision Date2022-10-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Renamel® Microhybrid ;Renamel® Flowable Microhybrid is a medical device manufactured by Cosmedent, Inc.. It received FDA 510(k) clearance on 2022-10-11 under approval number K222435. 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 Renamel® Microhybrid ;Renamel® Flowable Microhybrid?
Renamel® Microhybrid ;Renamel® Flowable Microhybrid is a medical device that received FDA 510(k) clearance on 2022-10-11. It is manufactured by Cosmedent, Inc.. The 510(k) number is K222435.
When was Renamel® Microhybrid ;Renamel® Flowable Microhybrid approved by the FDA?
Renamel® Microhybrid ;Renamel® Flowable Microhybrid received FDA 510(k) clearance on 2022-10-11, under approval number K222435.
What company makes Renamel® Microhybrid ;Renamel® Flowable Microhybrid?
Renamel® Microhybrid ;Renamel® Flowable Microhybrid is manufactured by Cosmedent, Inc..
What is the FDA product code for Renamel® Microhybrid ;Renamel® Flowable Microhybrid?
The FDA product code for Renamel® Microhybrid ;Renamel® Flowable Microhybrid 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.