FDA 510(k) Applications Submitted by Institut Straumann AG

FDA 510(k) Number Submission Date Device Name Applicant
K223083 09/30/2022 Straumann SLActive labeling changes Institut Straumann AG
K191256 05/10/2019 Straumann BLX ╪3.5 mm Implants Institut Straumann AG
K190040 01/08/2019 Straumann BLX Line Extension - New Abutments Institut Straumann AG
K193046 11/01/2019 Straumann« Retentive System û Novaloc TiN Abutments Institut Straumann AG
K120822 03/19/2012 STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST INSTITUT STRAUMANN AG
K171649 06/05/2017 Straumann CARES M-Series CAD/CAM System Institut Straumann AG
K093113 10/01/2009 ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT INSTITUT STRAUMANN AG
K180791 03/27/2018 Straumann BLX Surgical Cassette Institut Straumann AG
K003271 10/18/2000 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K033922 12/18/2003 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K201051 04/21/2020 Straumann BoneCeramic Institut Straumann AG
K173594 11/21/2017 Straumann cerabone Institut Straumann AG
K160262 02/02/2016 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG
K170356 02/06/2017 Straumann Variobase Abutments Institut Straumann AG
K170354 02/06/2017 Straumann Variobase Abutments Institut Straumann AG
K170420 02/13/2017 n!ce Glass Ceramic Blocks for Amann Girrbach Institut Straumann AG
K161677 06/17/2016 Straumann Sterile Healing Solution Institut Straumann AG
K162311 08/18/2016 Straumann PrefGel INSTITUT STRAUMANN AG
K162848 10/11/2016 Straumann CARES Golden Ti/TiN Abutments INSTITUT STRAUMANN AG
K173562 11/17/2017 Straumann Jason Membrane Institut Straumann AG
K173945 12/26/2017 Straumann SC Variobase Abutments Institut Straumann AG
K153758 12/30/2015 Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG
K230108 01/13/2023 Straumann« BLC and TLC Implants Institut Straumann AG
K212533 08/11/2021 BLX WB ╪5.0 (L18), ╪5.5 and ╪6.5 mm (L14 and L16) Implants Institut Straumann AG
K222836 09/20/2022 Straumann« Variobase« Abutments and Straumann« n!ce« Zirconia discs Institut Straumann AG
K060062 01/09/2006 STRAUMANN ORTHOSYSTEM INSTITUT STRAUMANN AG
K070549 02/26/2007 STRAUMANN P.004 RC GOLD ABUTMENT INSTITUT STRAUMANN AG
K070744 03/16/2007 NARROW NECK TEMPORARY COPING INSTITUT STRAUMANN AG
K081005 04/08/2008 P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG
K061176 04/27/2006 STRAUMANN DENTAL IMPLANTS INSTITUT STRAUMANN AG
K081186 04/28/2008 CONCAVE RN HEALING CAP INSTITUT STRAUMANN AG
K091701 06/10/2009 STRAUMANN MODIFIED DENTAL ABUTMENT INSTITUT STRAUMANN AG
K062129 07/26/2006 P.0004 IMPLANTS INSTITUT STRAUMANN AG
K072071 07/30/2007 STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS INSTITUT STRAUMANN AG
K082545 09/03/2008 STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG
K072497 09/05/2007 P.004 NC GOLD ABUTMENT FOR CROWNS INSTITUT STRAUMANN AG
K072679 09/21/2007 P.004 ABUTMENTS INSTITUT STRAUMANN AG
K082764 09/22/2008 STRAUMANN WN CARES TITANIUM ABUTMENT INSTITUT STRAUMANN AG
K213063 09/23/2021 TLX SRAs and TLX Gold Abutments Institut Straumann AG
K192029 07/30/2019 Straumann PUREloc abutments Institut Straumann AG
K190097 01/22/2019 Straumann CARES Screw-Retained Bridges and Bars Institut Straumann AG
K220878 03/25/2022 Straumann TLX Variobase C Institut Straumann AG
K192742 09/30/2019 Straumann Variobase C Institut Straumann AG
K173379 10/30/2017 Straumann Variobase for Crown AS Institut Straumann AG
K203456 11/23/2020 Straumann CARES M-Series CAD/CAM System Institut Straumann AG
K203750 12/23/2020 Straumann CARES P-Series CAD/CAM System Institut Straumann AG
K173968 12/29/2017 Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG
K101465 05/26/2010 STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR INSTITUT STRAUMANN AG
K191522 06/10/2019 Straumann Modular Cassette Institut Straumann AG
K040539 03/02/2004 ELLIPTIC MATRIX INSTITUT STRAUMANN AG
K041295 05/14/2004 RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT INSTITUT STRAUMANN AG
K192893 10/11/2019 Straumann Ceramic Healing Abutments Institut Straumann AG
K203355 11/16/2020 Straumann TLX Novaloc and Cementable Abutments Institut Straumann AG
K020096 01/11/2002 ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K011698 06/01/2001 STRAUMANN GBR SYSTEM INSTITUT STRAUMANN AG
K983742 10/23/1998 ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K053088 11/02/2005 SLACTIVE IMPLANTS INSTITUT STRAUMANN AG
K013798 11/15/2001 PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K013891 11/23/2001 SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT INSTITUT STRAUMANN AG
K033984 12/23/2003 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K081419 05/20/2008 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG
K082111 07/28/2008 STRAUMANN MEMBRAGEL INSTITUT STRAUMANN AG
K071357 05/15/2007 P.004 NC ANATOMIC ABUTMENTS INSTITUT STRAUMANN AG
K180477 02/22/2018 Straumann PURE Ceramic Implant System Institut Straumann AG
K190654 03/14/2019 Straumann CI RD Ceramic Healing Caps Institut Straumann AG
K200586 03/06/2020 Straumann TLX Implant System Institut Straumann AG
K171773 06/14/2017 Straumann n!ce Glass Ceramic A14 Blocks Institut Straumann AG
K172798 09/18/2017 Straumann CARES Abutments CoCr Institut Straumann AG
K173410 11/01/2017 n!ce for Planmill Institut Straumann AG
K190082 01/17/2019 Straumann BLX Variobase Abutment Institut Straumann AG
K220751 03/15/2022 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA Institut Straumann AG
K210855 03/23/2021 Straumann BLX Implant System Institut Straumann AG
K211052 04/09/2021 Straumann RidgeFit Implants Institut Straumann AG
K201681 06/22/2020 Straumann Immediate Temporary Abutments Institut Straumann AG
K181703 06/27/2018 Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments Institut Straumann AG
K191895 07/15/2019 Straumann Mini Implants Institut Straumann AG
K173961 12/28/2017 Straumann BLX Implant System Institut Straumann AG


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