Name: Predicase
Price: 199 USD

K-number	K965083
Device name	SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
Applicant	S.S. White Mfg., Ltd.
Product code	ELW
Device class	Class II
Decision date	Apr 4, 1997
Decision	Substantially Equivalent
Regulation	872.3660

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Source

View the full FDA submission: accessdata.fda.gov

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SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET

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