510(k) Report

Devices descending from K063216

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+1K211812BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd.20230—
+1K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+1K081302Rescue External Implant SystemMegagen Implant Co., Ltd.20084—
+1K080128SM-Extra Wide (RBM) Implant SystemDio Department Dsi, Inc.20080—
+1K073058Rescue Internal Implant SystemMegagen Co., Ltd.200896—
+2K210039CORE1 Implant SystemCybermed, Inc.20220—
+2K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+2K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+2K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+2K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+2K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+2K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+2K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+2K110337Universal Maxillary MolarOco Biomedical20121—
+2K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+2K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+2K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+3K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+3K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+3K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+3K220517IBS SystemInnobiosurg Co., Ltd.20220—
+3K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+3K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+3K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+3K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+3K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+3K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+3K111120CSM Submerged-R Implant SystemCsm Implant20118—
+3K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+3K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+3K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+4K240383Highness Implant SystemHighness Co., Ltd.20240—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+4K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+4K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+4K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+4K140600SB AnchorOsstem Implant Co., Ltd.20144—
+4K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+4K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+4K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223924LW Implant SystemOssvis Co., Ltd.20231—
+5K222451Save GBRDentis Co., Ltd.20230—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+5K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+5K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+5K192294I DoI DO Biotech Co., Ltd.20200—
+5K192747Yxoss CBR®Reoss GmbH20200—
+5K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+5K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+6K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—