510(k) Report

Devices descending from K151328

12 later devices reach PURE Ceramic Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+1K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+1K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20178—
+2K241391Straumann® PURE Ceramic ImplantsInstitut Straumann AG20240—
+2K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+2K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+2K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG20196—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+3K190654Straumann CI RD Ceramic Healing CapsInstitut Straumann AG20192—
+4K232383iPhysio® SystemEuroteknika20250—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—