510(k) Report

Devices descending from K011211

13 later devices reach Flowable Composite/ Ecuflow/ Luxaflow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140570Chairside Attachment Processing MaterialZest Anchors, LLC20140—
+1K013674Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc.200211—
+2K101710Luxatemp Ultra /StarDmg USA, Inc.20107—
+2K073296TEMPXN283M Espe AG Dental Products20084—
+3K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.20250—
+3K202965CURA-TempMgnewton, Ltd.20220—
+3K200039P pro Crown & BridgeDeltamed GmbH20201—
+3K191619TurboTemp EZZest Anchors, LLC20190—
+3K190930SmarTemp X1Parkell, Inc.20190—
+3K151144SuPro 1003M Deutschland GmbH20150—
+3K141562MSN-006GC America, Inc.20140—
+3K122039Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BKettenbach GmbH & Co. KG20120—
+4K243370DentaTOOTHAsiga Pty, Ltd.20250—