Name: Predicase
Price: 199 USD

K-number	K180252
Device name	Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
Applicant	Crown Porcelain Dental Technology Co., Ltd.
Product code	EIH
Device class	Class II
Decision date	Apr 24, 2018
Decision	Substantially Equivalent
Regulation	872.6660

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Source

View the full FDA submission: accessdata.fda.gov

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Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

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