510(k) Report

Devices descending from K171585

5 later devices reach LUXEN Zr, LUXEN Smile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262074Any-ZircosMediclus Co., Ltd.20260—
+1K241151Luxen 5GDentalmax Co., Ltd.20241—
+1K221429KDF Zirconia DiscDenken-Highdental Co., Ltd.20220—
+1K210097Estar-ZOsstem Implant Co., Ltd.20211—
+2K242521Estar-ZEOsstem Implant Co., Ltd.20240—