510(k) Report

Devices descending from K061319

67 later devices reach Spectra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+1K133050One Plus Implant SystemOsseofuse, Inc.20141—
+1K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+1K131701Z5MLB, Z5MLCZ-Systems AG20131—
+1K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+1K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+1K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+1K110337Universal Maxillary MolarOco Biomedical20121—
+1K090234Spectra System Dental Implants 2008Implant Direct, LLC20092211
+1K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+1K080633Screwindirect Dental ImplantsImplant Direct, LLC20080—
+1K080713Reactive Dental Implant SystemImplant Direct, LLC200823—
+1K073161Replus Dental Implants (HA)Implant Direct, LLC200843—
+1K073049Screwplus Dental Implants (HA)Implant Direct, LLC20070—
+1K073033Legacy Dental ImplantsImplant Direct, LLC200725—
+1K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC20250—
+2K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+2K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+2K200386Z5-BLZ-Systems AG20200—
+2K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+2K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+2K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+2K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+2K153650Microdent Ektos Implant SystemImplants Microdent System S.L20160—
+2K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+2K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+2K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+2K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+3K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+3K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—