Name: Predicase
Price: 199 USD

K-number	K160410
Device name	WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
Applicant	Dental Savings Club
Product code	EFB
Device class	Class I
Decision date	Sep 29, 2016
Decision	Substantially Equivalent
Regulation	872.4200

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

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