510(k) Report

Devices descending from K091812

4 later devices reach Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+2K170697GBR systemSurgident20182—
+3K222367Save GBRDentis Co., Ltd.20230—
+3K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—