Name: Predicase
Price: 199 USD

K-number	K120218
Device name	TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
Applicant	Palm Beach Dental Supply D/B/A Tek USA
Product code	EFB
Device class	Class I
Decision date	Jun 29, 2012
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)

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