510(k) Report

Devices descending from K010185

234 later devices reach 6.0 X 5.7MM Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+1K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+1K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+1K103810KJ Submerged SystemKj Meditech Co., Ltd.20111—
+1K093615Spi Dental Implant, ElementThommen Medical AG20101—
+1K073058Rescue Internal Implant SystemMegagen Co., Ltd.200896—
+1K053353Rescue Implant SystemMegagen Co., Ltd.2006118—
+1K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+2K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+2K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd.20220—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K171795Thommen Implant SystemThommen Medical AG20170—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+2K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+2K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+2K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+2K081302Rescue External Implant SystemMegagen Implant Co., Ltd.20084—
+2K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+2K063216Rescue Internal Implant SystemMegagen Co., Ltd.2007112—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+3K211812BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd.20230—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+3K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+3K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+3K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+3K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+3K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+3K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+3K110337Universal Maxillary MolarOco Biomedical20121—
+3K111120CSM Submerged-R Implant SystemCsm Implant20118—
+3K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+3K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+3K080128SM-Extra Wide (RBM) Implant SystemDio Department Dsi, Inc.20080—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240383Highness Implant SystemHighness Co., Ltd.20240—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+4K210039CORE1 Implant SystemCybermed, Inc.20220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+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—
+4K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+4K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+4K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—