510(k) Report

Devices descending from K950306

12 later devices reach Imtec Biobarrier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964342Cytoplast GBROsteogenics Co.199711—
+2K012144CytoflexUnicare Biomedical, Inc.20012—
+2K972278Cytoplast Regentex Titanium 250Osteogenics Co.199771
+3K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.20211—
+3K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…Salvin Dental Specialties20161—
+3K151344Cytoflex Tefguard Ti-Enforced MembraneUnicare Biomedical, Inc.20150—
+3K143327Neoss Ti Reinforced MembraneNeoss, Ltd.20152—
+3K091120Medpor Contain ImplantPorex Surgical, Inc.20101—
+4K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais20230—
+4K222549OpenTexPurgo Biologics, Inc.20230—
+4K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.20220—
+4K102184Medpor Contain Can ImplantPorex Surgical, Inc.20110—