Name: Predicase
Price: 199 USD

K-number	K212910
Device name	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Applicant	Shenzhen Carejoy Technology Co., Ltd.
Product code	EFB
Device class	Class I
Decision date	Nov 17, 2022
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece

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