K-number	K242435
Device name	Dental Barrier and Sleeves
Applicant	Wellmed Dental Medical Supply Co., Ltd.
Product code	PEM
Device class	Class II
Decision date	Oct 18, 2024
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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Dental Barrier and Sleeves

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