Name: Predicase
Price: 199 USD

K-number	K203499
Device name	Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
Applicant	Vatech Acucera, Inc.
Product code	EIH
Device class	Class II
Decision date	Apr 5, 2021
Decision	Substantially Equivalent
Regulation	872.6660

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank

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