510(k) Report

Devices descending from K961737

550 later devices reach Cera One Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+9K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+9K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+9K233389EK Digital AbutmentsHiossen, Inc.20240—
+9K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+9K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+9K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+9K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+9K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+9K223663SIMDA AbutmentSimda Co., Ltd.20232—
+9K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+9K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+9K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+9K222368Mist ICImagine Milling Technologies, LLC20222—
+9K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+9K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+9K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+9K212664SherlockOpen Implants, LLC20212—
+9K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+9K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+9K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+9K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+9K192742Straumann Variobase CInstitut Straumann AG20211—
+9K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+9K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+9K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+9K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+9K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+9K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+9K171532TruBase STruabutment, Inc.20187—
+9K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+9K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+9K170421ET Hybrid AbutmentHiossen, Inc.20180—
+9K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+9K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+9K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+9K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+9K160786RODO Abutment SystemRodo Medical, Inc.20162—
+9K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+9K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K150295LOCATOR RTxZest Anchors, Inc.201542—
+9K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+9K142167Medentika Abutment SystemMedentika GmbH20157—
+9K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+10K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+10K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+10K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+10K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+10K243009Mist ICImagine Milling Technologies, LLC20251—
+10K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+10K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+10K241032BellaTek BarsBiomet 3i, LLC20241—
+10K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+10K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+10K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+10K232271SIMDA abutmentSimda Co., Ltd.20230—
+10K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+10K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+10K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+10K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+10K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+10K221966Dynamic TiBaseTalladium Espana, SL20225—
+10K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+10K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+10K220482SherlockOpen Implants, LLC20221—
+10K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+10K212108Dynamic TiBaseTalladium España, SL20219—
+10K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+10K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+10K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+10K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+10K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+10K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+10K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+10K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+10K180609Rodo SmilekeyRodo Medical, Inc.20180—
+10K170394Kisses MiniAchimhai Medical Corporation20170—
+10K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+10K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+10K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+11K260940BellaTek BarsZimVie US Corp, LLC20260—
+11K261122Mist ICImagine Milling Technologies, LLC20260—
+11K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+11K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+11K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+11K253341Custom Abutments ASMedentika GmbH20250—
+11K250967SherlockOpen Implants, LLC20250—
+11K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+11K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+11K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+11K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+11K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+11K231559Multi-Unit DAS SystemTalladium España, SL20231—
+11K232151Dynamic TiBaseTalladium España, SL20232—
+11K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+11K221673Bonafix TiBaseZentek Medical, LLC20231—