K-number	K213965
Device name	BeautiBond Xtreme
Applicant	Shofu Dental Corporation
Product code	KLE
Device class	Class II
Decision date	Mar 18, 2022
Decision	Substantially Equivalent
Regulation	872.3200

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Source

View the full FDA submission: accessdata.fda.gov

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BeautiBond Xtreme

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