Name: Predicase
Price: 199 USD

K-number	K212475
Device name	Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Applicant	Prevest Denpro Limited
Product code	EJK
Device class	Class II
Decision date	May 13, 2022
Decision	Substantially Equivalent
Regulation	872.3250

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Source

View the full FDA submission: accessdata.fda.gov

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Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

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