K-number	K971603
Device name	STERILE SUREFLEX FILES AND INSTRUMENTS
Applicant	Dentsply Intl.
Product code	EFA
Device class	Class I
Decision date	Jun 4, 1997
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE SUREFLEX FILES AND INSTRUMENTS

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