Renamel Bulkfill
K-Number: K211259 · 2021-06-24
ApplicantCosmedent, Inc.
Decision Date2021-06-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Renamel Bulkfill is a medical device manufactured by Cosmedent, Inc.. It received FDA 510(k) clearance on 2021-06-24 under approval number K211259. 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 Bulkfill?
Renamel Bulkfill is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Cosmedent, Inc.. The 510(k) number is K211259.
When was Renamel Bulkfill approved by the FDA?
Renamel Bulkfill received FDA 510(k) clearance on 2021-06-24, under approval number K211259.
What company makes Renamel Bulkfill?
Renamel Bulkfill is manufactured by Cosmedent, Inc..
What is the FDA product code for Renamel Bulkfill?
The FDA product code for Renamel Bulkfill 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.