K-number	K112153
Device name	IROOT 100 MINI
Applicant	S-Denti Co., Ltd.
Product code	LQY
Device class	Class U
Decision date	Apr 26, 2012
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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IROOT 100 MINI

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