510(k) Report

Devices descending from K002513

426 later devices reach Astra Tech Implants - Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093749GC Aadva Implant SystemGC America, Inc.20100—
+1K072425Jne Implant SystemGC America, Inc.20081—
+1K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc.2003423—
+2K083670Universal, Aesthetica, Natea, NaturaEuroteknika20090—
+2K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc.2007209—
+2K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007357—
+2K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+3K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+3K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+3K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+3K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc.2011202—
+3K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+3K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+3K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc.2008337—
+3K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+3K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+3K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+3K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K150040ImplanovaDental Evolutions, Inc.20150—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+4K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+4K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K160786RODO Abutment SystemRodo Medical, Inc.20162—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—