Name: Predicase
Price: 199 USD

K-number	K172761
Device name	New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
Applicant	Shanghai New Century Dental Materials Co., Ltd.
Product code	EIH
Device class	Class II
Decision date	Nov 17, 2017
Decision	Substantially Equivalent
Regulation	872.6660

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Source

View the full FDA submission: accessdata.fda.gov

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New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)

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