510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+4K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+4K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+4K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+4K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K221752StellaShinhung Mst Co., Ltd.20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—