Name: Predicase
Price: 199 USD

K-number	K230895
Device name	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
Applicant	Cefla S.C.
Product code	EBW
Device class	Class I
Decision date	Apr 1, 2024
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,

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