K-number	K222144
Device name	IR SLA Type Implant System
Applicant	Biotem Co., Ltd.
Product code	DZE
Device class	Class II
Decision date	Jun 14, 2023
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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IR SLA Type Implant System

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