510(k) Report

Devices descending from K101710

7 later devices reach Luxatemp Ultra /Star through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.20250—
+1K200039P pro Crown & BridgeDeltamed GmbH20201—
+1K191619TurboTemp EZZest Anchors, LLC20190—
+1K190930SmarTemp X1Parkell, Inc.20190—
+1K141562MSN-006GC America, Inc.20140—
+1K122039Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BKettenbach GmbH & Co. KG20120—
+2K243370DentaTOOTHAsiga Pty, Ltd.20250—