510(k) Report

Devices descending from K053353

118 later devices reach Rescue Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+1K081302Rescue External Implant SystemMegagen Implant Co., Ltd.20084—
+1K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+1K063216Rescue Internal Implant SystemMegagen Co., Ltd.2007112—
+2K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+2K211812BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd.20230—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+2K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+2K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+2K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+2K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+2K110337Universal Maxillary MolarOco Biomedical20121—
+2K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+2K080128SM-Extra Wide (RBM) Implant SystemDio Department Dsi, Inc.20080—
+2K073058Rescue Internal Implant SystemMegagen Co., Ltd.200896—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+3K210039CORE1 Implant SystemCybermed, Inc.20220—
+3K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+3K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+3K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+3K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+3K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+3K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+3K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+3K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+3K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+4K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+4K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+4K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+4K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+4K220517IBS SystemInnobiosurg Co., Ltd.20220—
+4K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+4K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+4K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+4K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+4K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+4K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+4K111120CSM Submerged-R Implant SystemCsm Implant20118—
+4K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+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—
+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—
+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—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+5K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+5K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+5K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+5K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K140600SB AnchorOsstem Implant Co., Ltd.20144—
+5K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+5K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+5K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K223924LW Implant SystemOssvis Co., Ltd.20231—
+6K222451Save GBRDentis Co., Ltd.20230—
+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
+6K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K192294I DoI DO Biotech Co., Ltd.20200—
+6K192747Yxoss CBR®Reoss GmbH20200—
+6K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K172100URIS OMNI SystemTruabutment, Inc.20187—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—