K-number	K943584
Device name	PRESTERILIZED ENDODONTIC FILES
Applicant	Dentsply Intl.
Product code	EKJ
Device class	Class I
Decision date	Sep 21, 1994
Decision	Substantially Equivalent
Regulation	872.4565

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View the full FDA submission: accessdata.fda.gov

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PRESTERILIZED ENDODONTIC FILES

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