Name: Predicase
Price: 199 USD

K-number	K030133
Device name	SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
Applicant	Dentalez Group
Product code	EBF
Device class	Class II
Decision date	Apr 29, 2003
Decision	Substantially Equivalent
Regulation	872.3690

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Source

View the full FDA submission: accessdata.fda.gov

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SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE

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