510(k) Report

Devices descending from K023631

307 later devices reach Astra Tech Dental Implants-Ceramic Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+1K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+1K061567Biohorizons Ceramic AbutmentBioHorizons Implant Systems, Inc.20060—
+1K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+1K051501ZiraceAcucera, Inc.20058—
+2K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+2K150040ImplanovaDental Evolutions, Inc.20150—
+2K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+2K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+2K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+2K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+2K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+2K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH20077—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+3K232528Protective CapNeobiotech Co., Ltd.20240—
+3K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+3K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K231079LW Retraction CapOssvis Co., Ltd.20230—
+3K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K221752StellaShinhung Mst Co., Ltd.20230—
+3K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K213599SuperLineDentium Co., Ltd.20220—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+3K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+3K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+3K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+3K160786RODO Abutment SystemRodo Medical, Inc.20162—
+3K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K160244VARIOuniteThommen Medical AG201615—
+3K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+3K150295LOCATOR RTxZest Anchors, Inc.201542—
+3K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K133991ISYAltatec GmbH20142—
+3K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+3K131165Anker Dental Implant SystemAlliance Global20131—
+3K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+3K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+3K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+3K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+3K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+3K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+3K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+3K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+4K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—