510(k) Report

Devices descending from K921468

33 later devices reach Permamesh Hydroxylapatite Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816—
+1K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+2K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+2K101426Ceros TCP GranulesMathys, Ltd.20100—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+2K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+3K071663VF Gel PlusCoapt Systems, Inc.20084—
+3K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+4K081815Vocalis GelCytophil, Inc.20090—
+4K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+4K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K180631Silk VoiceSofregen Medical, Inc.20181—
+5K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+5K083783VF LiquigelCoapt Systems, Inc.20090—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K240919Silk Voice (SMI-04)Sofregen Medical20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—