Name: Predicase
Price: 199 USD

K-number	K081514
Device name	TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
Applicant	Lang Dental Mfg. Co., Inc.
Product code	EBI
Device class	Class II
Decision date	Sep 22, 2008
Decision	Substantially Equivalent
Regulation	872.3760

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Source

View the full FDA submission: accessdata.fda.gov

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TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER

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