K-number	K191276
Device name	Dental Electrical Motor iRoot Pro
Applicant	Changzhou Bomedent Medical Technology Co.,Ltd
Product code	EKX
Device class	Class I
Decision date	Jun 30, 2020
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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Dental Electrical Motor iRoot Pro

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