Diapex Plus
K-Number: K182625 · 2019-06-03
ApplicantDiaDent Group International
Decision Date2019-06-03
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Diapex Plus is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2019-06-03 under approval number K182625. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Diapex Plus?
Diapex Plus is a medical device that received FDA 510(k) clearance on 2019-06-03. It is manufactured by DiaDent Group International. The 510(k) number is K182625.
When was Diapex Plus approved by the FDA?
Diapex Plus received FDA 510(k) clearance on 2019-06-03, under approval number K182625.
What company makes Diapex Plus?
Diapex Plus is manufactured by DiaDent Group International.
What is the FDA product code for Diapex Plus?
The FDA product code for Diapex Plus is KIF.
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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.