K-number	K192682
Device name	Orthocem, Ortho Bite
Applicant	Dentscare Ltda
Product code	DYH
Device class	Class II
Decision date	Aug 14, 2020
Decision	Substantially Equivalent
Regulation	872.3750

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Source

View the full FDA submission: accessdata.fda.gov

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Orthocem, Ortho Bite

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