510(k) Report

Devices descending from K163385

4 later devices reach Cortex Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182615Surgikor Dental Implant SystemSurgikor, LLC20193—
+2K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+2K242217Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd.20250—
+2K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—