Estelite Universal Flow
K-Number: K180613 · 2018-07-12
ApplicantTokuyama Dental Corporation
Decision Date2018-07-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Estelite Universal Flow is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2018-07-12 under approval number K180613. 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 Universal Flow?
Estelite Universal Flow is a medical device that received FDA 510(k) clearance on 2018-07-12. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K180613.
When was Estelite Universal Flow approved by the FDA?
Estelite Universal Flow received FDA 510(k) clearance on 2018-07-12, under approval number K180613.
What company makes Estelite Universal Flow?
Estelite Universal Flow is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for Estelite Universal Flow?
The FDA product code for Estelite Universal Flow 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.