Name: Predicase
Price: 199 USD

K-number	K213947
Device name	Ultrasonic Endo Activation Device (Model:Actor I pro)
Applicant	Changzhou Bomedent Medical Technology Co.,Ltd
Product code	ELC
Device class	Class II
Decision date	Sep 8, 2022
Decision	Substantially Equivalent
Regulation	872.4850

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Source

View the full FDA submission: accessdata.fda.gov

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Ultrasonic Endo Activation Device (Model:Actor I pro)

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