ESTELITE BULK FILL Flow
K-Number: K161353 · 2017-04-03
ApplicantTokuyama Dental Corporation
Decision Date2017-04-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ESTELITE BULK FILL Flow is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2017-04-03 under approval number K161353. 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 ESTELITE BULK FILL Flow?
ESTELITE BULK FILL Flow is a medical device that received FDA 510(k) clearance on 2017-04-03. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K161353.
When was ESTELITE BULK FILL Flow approved by the FDA?
ESTELITE BULK FILL Flow received FDA 510(k) clearance on 2017-04-03, under approval number K161353.
What company makes ESTELITE BULK FILL Flow?
ESTELITE BULK FILL Flow is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for ESTELITE BULK FILL Flow?
The FDA product code for ESTELITE BULK FILL Flow is EBF.
Other Devices by Tokuyama Dental Corporation
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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.