510(k) Report

Devices descending from K073161

43 later devices reach Replus Dental Implants (HA) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+1K080713Reactive Dental Implant SystemImplant Direct, LLC200823—
+2K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K090234Spectra System Dental Implants 2008Implant Direct, LLC20092211
+3K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC20250—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+3K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+3K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+3K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+3K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+4K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+6K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+6K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—