510(k) Report

Devices descending from K982509

66 later devices reach Ortho Implant and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062733Tomas Pin SD 6, 8, and 10 MMDentaurum20066—
+1K060062Straumann OrthosystemInstitut Straumann AG200612
+1K042965Tomas PinDentaurum, Inc.200526—
+1K040469The Straumann Ortho Implant SystemThe Straumann Co.20042—
+1K033767Dual Top Anchor System ScrewsJeil Medical Corporation200454—
+1K031936Osteomed Orthodontic Screw SystemOsteomed LP200463—
+2K120861Fin-S MicroimplantCreekside Orthodontics20130—
+2K113650Orthofix ScrewBonafix Surgical and Dental Implants, LLC20121—
+2K110275Ortho Easy PinForestadent Bernhard Forster GmbH20111—
+2K093299Synthes Orthodontic Bone Anchor SystemSynthes (Usa)20103—
+2K082838Orlus Mini ScrewOrtholution Co., Ltd.20081—
+2K081393Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co.20080—
+2K073461Ortho Anchor ScrewsMis Implants Technologies, Ltd.20080—
+2K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+2K071851HDC Sterile Spider ScrewHdc S.R.L.20072—
+2K063770Alpha-Bio Orthodontic Fixation Screw SystemAlpha-Bio Tec, Ltd.20071—
+2K063149Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC20072—
+2K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A.20061—
+2K062156Super Orthodontic ScrewOsstem Implant Co., Ltd.20066—
+2K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Ace Surgical Supply Co., Inc.20066—
+2K060500Speedy Orthodontic ScrewDentium Co., Ltd.20060—
+2K053629Anchor Plus/Neo Anchor PlusKj Meditech20060—
+2K060126Absoanchor MicroimplantDentos, Inc.200619—
+2K052471HDC Spider ScrewHdc S.R.L.20054—
+2K051552O.a.S.I. SystemLancer Orthodontics, Inc.20050—
+2K050568Orlus Mini ScrewOrtholution Co., Ltd.20055—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)20260—
+3K201919Blue Sky Bio TADBlue Sky Bio, LLC20200—
+3K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+3K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+3K170697GBR systemSurgident20182—
+3K143730GBR SystemJeil Medical Corporation20152—
+3K122069Storm Mini ScrewLancer Orthodontics, Inc.20130—
+3K103105Orthodontic ScrewOsstem Implant Co., Ltd.20114—
+3K102769Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S20110—
+3K091390HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L.20090—
+3K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+3K071490Leone Orthodontic Mini ImplantLeone S.P.A.200814—
+3K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc.20085—
+3K052968Modification to: Orlus Mini ScrewOrtholution Co., Ltd.20062—
+4K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K211992Ortho MI SystemOsteonic Co., Ltd.20210—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+4K161197Orthodontic ScrewOsstem Implant Co., Ltd.20162—
+4K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+4K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+4K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp.200913—
+5K231502Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi20240—
+5K202790Syntec Orthodontic Mini Screw Extended SystemSyntec Scientific Corporation20210—
+5K190871Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd.20200—
+5K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd.20190—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K152297OBS Anchorage ScrewBomei Co, Ltd.20161—
+5K142001Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office20151—
+5K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+5K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions20115—
+6K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.20250—
+6K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.20220—
+6K202278OBS Anchorage Screw, Biokey Anchorage ScrewBomei Co, Ltd.20210—
+6K161335Dual Top Screw SystemJeil Medical Corporation20173—
+7K231913T-FITTechwin Co., Ltd.20240—
+7K210559ATOZ Mini-ScrewMk Meditech, Inc.20210—
+7K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd.20200—