510(k) Report

Devices descending from K981516

1,066 later devices reach Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+5K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K163043Zeramex P6 Dental Implant SystemDentalpoint AG20160—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+5K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K141188Microdent Genius Implant SystemImplant Microdent20150—
+5K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K133050One Plus Implant SystemOsseofuse, Inc.20141—
+5K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+5K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+5K123471Etii SA Fixture SystemHiossen, Inc.201314—
+5K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+5K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+5K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K110337Universal Maxillary MolarOco Biomedical20121—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K112730Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i201292
+5K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+5K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+5K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+5K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas201131
+5K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—