510(k) Report

Devices descending from K031719

514 later devices reach Esthetic Zirconia Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180899Universal Base AbutmentNobel Biocare AB20189—
+1K133377Nobelprocera Angulated Screw Channel Abutment ReplaceNobel Biocare AB20141—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+1K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+1K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+1K063592Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553…Nobel Biocare AB20070—
+1K051501ZiraceAcucera, Inc.20058—
+1K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc.2004441—
+1K041275Procera Abutment OctagonNobel Biocare Uas, Inc.200461—
+2K231455Implant-One SystemImplant Logistics, Inc.20230—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+2K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+2K200040Universal Base Conical Connection (CC)Nobel Biocare AG20203—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+2K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K151439Atlantis IsusDentsply International, Inc.20160—
+2K152555Dental Implant SystemAriabio International, Inc.20160—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+2K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+2K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+2K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+2K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+2K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+2K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+2K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+2K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH20077—
+2K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+2K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+2K052823Implantium AbutmentsDentium, Inc.200621—
+2K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Atlantis Components, Inc.2005261—
+3K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+3K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+3K220022TRATE Dental Implant SystemTrate AG20221—
+3K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+3K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—