K-number	K182625
Device name	Diapex Plus
Applicant	DiaDent Group International
Product code	KIF
Device class	Class II
Decision date	Jun 3, 2019
Decision	Substantially Equivalent
Regulation	872.3820

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Source

View the full FDA submission: accessdata.fda.gov

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Diapex Plus

Everything you need for a 510(k) submission. Nothing you don't.