510(k) Report

Devices descending from K981647

11 later devices reach 3M Dent II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151094Mosaic Universal CompositeUltradent Products, Inc.20151—
+1K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products20128—
+2K242713Any-Com BulkMediclus Co., Ltd.20250—
+2K242014Jet Flow BulkMeta Biomed Co., Ltd.20240—
+2K240694FORMA Composite (Shade A3D)Ultradent Products, Inc.20240—
+2K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+2K182714Novidia Bulk Fill Flow CompositeNobio, Ltd.20192—
+2K141994Bulk Fill Flowable CompositeNovocol, Inc.20140—
+2K140512Ufill Bulk Fill Posterior Flowable CompositeJuno Dentistry LP20140—
+3K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd.20201—
+4K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company20250—