510(k) Report

Devices descending from K993595

942 later devices reach Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K123471Etii SA Fixture SystemHiossen, Inc.201314—
+7K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+7K120414Osseospeed PlusAstra Tech AB2012196—
+7K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+7K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+7K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+7K111287Astra Tech Implant SystemAstra Tech AB2011201—
+7K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+7K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+7K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+8K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+8K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+8K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K241032BellaTek BarsBiomet 3i, LLC20241—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K223924LW Implant SystemOssvis Co., Ltd.20231—
+8K221107TRUSTRgorithm Korea20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+8K222451Save GBRDentis Co., Ltd.20230—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+8K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+8K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+8K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+8K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+8K211225MIS Ti-base abutmentDentsply Sirona20210—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+8K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+8K192294I DoI DO Biotech Co., Ltd.20200—
+8K192747Yxoss CBR®Reoss GmbH20200—
+8K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+8K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+8K173570SD AbutmentSurgident Co., Ltd.20190—
+8K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+8K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+8K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+8K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+8K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd.20181—
+8K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+8K161923J2A SLA Dental Implant SystemKj Meditech Co., Ltd.20171—
+8K170259TruAbutment DSTruabutment201717—
+8K160536Chaorum Implant SystemMedimecca Co., Ltd.20173—
+8K160786RODO Abutment SystemRodo Medical, Inc.20162—
+8K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+8K150295LOCATOR RTxZest Anchors, Inc.201542—
+8K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+8K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+8K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+8K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+9K260940BellaTek BarsZimVie US Corp, LLC20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+9K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.20250—
+9K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+9K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd.20240—
+9K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+9K231932TDS (Techwin Dental System)Techwin Co., Ltd.20240—
+9K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+9K230725NB Implant SystemArum Dentistry Co., Ltd.20231—
+9K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—