510(k) Report

Devices descending from K041655

91 later devices reach Bio Plant System (Implants and Abutments) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052369Exfeel Implant SystemMegagen Co., Ltd.200684—
+1K050635Allfim Implant SystemsCowellmedi Co., Ltd.20055—
+2K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+2K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+2K142426EBI External Implant SystemEbi, Inc.20150—
+2K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+2K090174Tsi; EriOco Biomedical20094—
+2K071148Atlas Implant SystemCowellmedi Co., Ltd.20084—
+2K070562EZ Plus Implant SystemMegagen Co., Ltd.200774—
+3K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+3K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+3K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+3K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K120043CSM Internal-R Implant SystemCsm Implant20121—
+3K110337Universal Maxillary MolarOco Biomedical20121—
+3K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+3K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+3K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+4K242261Accelx Implant SystemBiotech Dental, LLC20240—
+4K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+4K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+4K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+4K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+4K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+4K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+5K240383Highness Implant SystemHighness Co., Ltd.20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K213599SuperLineDentium Co., Ltd.20220—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+8K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—