Name: Predicase
Price: 199 USD

K-number	K242675
Device name	FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
Applicant	Spident Co., Ltd.
Product code	KLE
Device class	Class II
Decision date	Nov 1, 2024
Decision	Substantially Equivalent
Regulation	872.3200

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Source

View the full FDA submission: accessdata.fda.gov

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FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)

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