510(k) Report

Devices descending from K940459

21 later devices reach Multipurpose Resin Cement with Fluoride (MRCF) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040906Calibra CementDentsply Intl.20048—
+1K981965Flowable CompositeDentsply Intl.199811—
+2K182288TPH Spectra ST Flowable Composite RestorativeDentsply Sirona20180—
+2K101787Duolink IIBisco, Inc.20101—
+2K083841Adaptable Composite Resin Restorative MaterialDentsply International, Inc.20099—
+2K083326Fluorocore 2Dentsply International, Inc.20091—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K250156Choice 2 DCBisco, Inc.20250—
+3K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+3K171449MetacemMeta Biomed Co., Ltd.20181—
+3K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products20128—
+3K101504TI-Core FlowEssential Dental Systems, Inc.20100—
+4K261166Dia-CemDiaDent Group International20260—
+4K242713Any-Com BulkMediclus Co., Ltd.20250—
+4K242014Jet Flow BulkMeta Biomed Co., Ltd.20240—
+4K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+4K182714Novidia Bulk Fill Flow CompositeNobio, Ltd.20192—
+4K141994Bulk Fill Flowable CompositeNovocol, Inc.20140—
+4K140512Ufill Bulk Fill Posterior Flowable CompositeJuno Dentistry LP20140—
+5K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd.20201—
+6K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company20250—