510(k) Report

Devices descending from K100850

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—