K-number	K240586
Device name	Additive Manufacturing Zirconia Customized Restoration
Applicant	Hangzhou Thales Medtech Co., Ltd.
Product code	ELL
Device class	Class II
Decision date	Oct 3, 2024
Decision	Substantially Equivalent
Regulation	872.3920

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Source

View the full FDA submission: accessdata.fda.gov

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Additive Manufacturing Zirconia Customized Restoration

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