510(k) Report

Devices descending from K913255

616 later devices reach Ceramic (TM) Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+4K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K201712Z5-TLZ-Systems AG20200—
+4K200386Z5-BLZ-Systems AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+4K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+4K190243Z5-BLZ-Systems AG20202—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+4K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K142260NobelActiveNobel Biocare AB201599—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+4K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+4K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K120043CSM Internal-R Implant SystemCsm Implant20121—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—