K-number	K193405
Device name	Simplant Digital Guide
Applicant	Dentsply Sirona
Product code	NDP
Device class	Class I
Decision date	Sep 2, 2020
Decision	Substantially Equivalent
Regulation	872.3980

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Source

View the full FDA submission: accessdata.fda.gov

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Simplant Digital Guide

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