510(k) Report

Devices descending from K891615

495 later devices reach Surgical Drills through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+6K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+6K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+6K101545Genesis Implant SystemKeystone Dental2010153
+6K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+6K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+6K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+6K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+6K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+6K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+6K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+7K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+7K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+7K251280DESS® Dental ImplantsTerrats Medical SL20250—
+7K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K232383iPhysio® SystemEuroteknika20250—
+7K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K242261Accelx Implant SystemBiotech Dental, LLC20240—
+7K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+7K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+7K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+7K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K211872PiezoImplant SystemRex Implants, Inc.20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+7K213599SuperLineDentium Co., Ltd.20220—
+7K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+7K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+7K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+7K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+7K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+7K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K182246Mist ICImagine Milling Technologies, LLC20194—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K183518Preat AbutmentsPreat Corporation2019223
+7K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+7K173701Implant-One SystemImplant Logistics, Inc.20181—
+7K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+7K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+7K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K171795Thommen Implant SystemThommen Medical AG20170—
+7K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+7K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+7K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+7K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+7K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+7K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+7K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+7K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+7K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+7K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+7K160244VARIOuniteThommen Medical AG201615—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+7K153779Abutment for BridgesAltatec GmbH20161—