510(k) Report

Devices descending from K990342

696 later devices reach Synocta Prosthetics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+4K133991ISYAltatec GmbH20142—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K131526Sfi-BarCendres & Metaux SA20130—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+4K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+4K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+4K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K082764Straumann WN Cares Titanium AbutmentInstitut Straumann AG2008171—
+4K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+4K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+4K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+4K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+4K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+4K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+4K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K192742Straumann Variobase CInstitut Straumann AG20211—