510(k) Report

Devices descending from K092035

165 later devices reach Bicon Implants with a 2.5MM Internal Connection through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231566ICX-Implant SystemMedentis Medical GmbH20240—
+1K211409Proximerge 2 Dental Implant SystemQuadric Biomed, LLC20220—
+1K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+1K213599SuperLineDentium Co., Ltd.20220—
+1K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+1K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+1K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+1K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+1K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+1K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+1K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+1K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+1K103810KJ Submerged SystemKj Meditech Co., Ltd.20111—
+2K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+2K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+2K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+2K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+2K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+2K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+2K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+2K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd.20220—
+2K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+2K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+2K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+2K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+2K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+3K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+3K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+3K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+3K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+3K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+3K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+4K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243278Custom AbutmentsInstitut Straumann AG202501
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—