Name: Predicase
Price: 199 USD

K-number	K242360
Device name	Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Applicant	Dent4you AG
Product code	ELW
Device class	Class II
Decision date	Nov 15, 2024
Decision	Substantially Equivalent
Regulation	872.3660

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

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