Name: Predicase
Price: 199 USD

K-number	K001108
Device name	PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
Applicant	Prime Dental Manufacturing, Inc.
Product code	EBF
Device class	Class II
Decision date	May 30, 2000
Decision	Substantially Equivalent
Regulation	872.3690

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Source

View the full FDA submission: accessdata.fda.gov

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PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

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