510(k) Report

Devices descending from K991947

565 later devices reach 3I Ceramic Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K201712Z5-TLZ-Systems AG20200—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200386Z5-BLZ-Systems AG20200—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K190243Z5-BLZ-Systems AG20202—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K161435Temporary Snap AbutmentNobel Biocare AB201601
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—