DiaFil Flow
K-Number: K192284 · 2020-03-25
ApplicantDiaDent Group International
Decision Date2020-03-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DiaFil Flow is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-03-25 under approval number K192284. 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 DiaFil Flow?
DiaFil Flow is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by DiaDent Group International. The 510(k) number is K192284.
When was DiaFil Flow approved by the FDA?
DiaFil Flow received FDA 510(k) clearance on 2020-03-25, under approval number K192284.
What company makes DiaFil Flow?
DiaFil Flow is manufactured by DiaDent Group International.
What is the FDA product code for DiaFil Flow?
The FDA product code for DiaFil 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.