510(k) Report

Devices descending from K981965

11 later devices reach Flowable Composite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182288TPH Spectra ST Flowable Composite RestorativeDentsply Sirona20180—
+1K083841Adaptable Composite Resin Restorative MaterialDentsply International, Inc.20099—
+2K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products20128—
+3K242713Any-Com BulkMediclus Co., Ltd.20250—
+3K242014Jet Flow BulkMeta Biomed Co., Ltd.20240—
+3K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+3K182714Novidia Bulk Fill Flow CompositeNobio, Ltd.20192—
+3K141994Bulk Fill Flowable CompositeNovocol, Inc.20140—
+3K140512Ufill Bulk Fill Posterior Flowable CompositeJuno Dentistry LP20140—
+4K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd.20201—
+5K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company20250—