510(k) Report

Devices descending from K100235

21 later devices reach Filtek Supreme Ultra Flowable Restorative through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221510TrusFIL-Flow Flowable Composite RestorativeRizhao Huge Biomaterials Company, Ltd.20220—
+1K213339DENU Composite Resin, DENU Flow ResinHdi, Inc.20221—
+1K2216953M Filtek Supreme Flowable Restorative3M Company Espe Dental Products20221—
+1K182580Novidia Flowable CompositeNobio, Ltd.20193—
+1K180463Apoller Flow Light Cure Flowable CompositeGreenway Yw, LLC20180—
+1K150623Nanova Flowable CompositeNanova Biomaterials, Inc.20150—
+1K130672Optiflow II Flowable Composite, LCPac-Dent International, Inc.20130—
+1K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products20128—
+1K103190Profil Composites (Profil, Profil Flow)Silmet, Ltd.20111—
+2K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.20260—
+2K242713Any-Com BulkMediclus Co., Ltd.20250—
+2K242014Jet Flow BulkMeta Biomed Co., Ltd.20240—
+2K240823els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG20240—
+2K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+2K220077IMICRYL Composite, Composite Flow MaterialsImicryl Dis Malzemeleri Sanayi VE Ticaret AS20220—
+2K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd.20201—
+2K182921Infinix Universal CompositeNobio, Ltd.20192—
+2K182714Novidia Bulk Fill Flow CompositeNobio, Ltd.20192—
+2K141994Bulk Fill Flowable CompositeNovocol, Inc.20140—
+2K140512Ufill Bulk Fill Posterior Flowable CompositeJuno Dentistry LP20140—
+3K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company20250—