Institut Straumann AG
Medical device manufacturer in Basel, CH.
92510(k) clearances
0PMA approvals
0recalls
Device types
- NHA Abutment, Implant, Dental, Endosseous 47
- DZE Implant, Endosseous, Root-Form 31
- EIH Powder, Porcelain 3
- KCT Sterilization Wrap Containers, Trays… 3
- JEY Plate, Bone 1
- OAT Implant, Endosseous, Orthodontic 1
- NPK Barrier, Synthetic, Intraoral 1
- KJJ Cleanser, Root Canal 1
- NPL Barrier, Animal Source, Intraoral 1
- NPM Bone Grafting Material, Animal Source 1
- LYC Bone Grafting Material, Synthetic 1
- PNP Dental Abutment Design Software For Dental… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | 06/03/2026SE |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional | 05/07/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | 03/10/2026SE |
| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
| K230108 | Straumann® BLC and TLC ImplantsDZE · Traditional | 09/14/2023SE |
| K223083 | Straumann SLActive labeling changesDZE · Traditional | 06/22/2023SE |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsNHA · Traditional | 05/15/2023SE |
| K220878 | Straumann TLX Variobase CNHA · Traditional | 06/16/2022SE |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMANHA · Traditional | 06/02/2022SE |
| K213063 | TLX SRAs and TLX Gold AbutmentsNHA · Traditional | 04/08/2022SE |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsDZE · Traditional | 01/28/2022SE |
| K203750 | Straumann CARES P-Series CAD/CAM SystemNHA · Traditional | 10/09/2021SE |
| K211052 | Straumann RidgeFit ImplantsDZE · Traditional | 07/08/2021SE |
| K203456 | Straumann CARES M-Series CAD/CAM SystemNHA · Special | 06/23/2021SE |
| K210855 | Straumann BLX Implant SystemDZE · Traditional | 06/21/2021SE |
| K201681 | Straumann Immediate Temporary AbutmentsNHA · Traditional | 03/18/2021SE |
| K203355 | Straumann TLX Novaloc and Cementable AbutmentsNHA · Traditional | 02/12/2021SE |
| K192742 | Straumann Variobase CNHA · Traditional | 02/12/2021SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | 09/24/2020SE |
| K200586 | Straumann TLX Implant SystemDZE · Traditional | 08/20/2020SE |
| K193046 | Straumann® Retentive System Novaloc TiN AbutmentsNHA · Traditional | 08/13/2020SE |
| K192893 | Straumann Ceramic Healing AbutmentsNHA · Traditional | 01/03/2020SE |
| K191256 | Straumann BLX Ø3.5 mm ImplantsDZE · Traditional | 12/27/2019SE |
| K191895 | Straumann Mini ImplantsDZE · Traditional | 12/09/2019SE |
| K191522 | Straumann Modular CassetteKCT · Traditional | 12/03/2019SE |
| K192029 | Straumann PUREloc abutmentsNHA · Traditional | 10/28/2019SE |
| K190654 | Straumann CI RD Ceramic Healing CapsNHA · Traditional | 06/28/2019SE |
| K190097 | Straumann CARES Screw-Retained Bridges and BarsNHA · Traditional | 06/26/2019SE |
| K190082 | Straumann BLX Variobase AbutmentNHA · Traditional | 04/17/2019SE |
| K190040 | Straumann BLX Line Extension - New AbutmentsNHA · Traditional | 04/08/2019SE |
| K180477 | Straumann PURE Ceramic Implant SystemDZE · Traditional | 01/04/2019SE |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZE · Traditional | 12/28/2018SE |
| K173594 | Straumann ceraboneNPM · Traditional | 10/19/2018SE |
| K173945 | Straumann SC Variobase AbutmentsNHA · Traditional | 10/05/2018SE |
| K173968 | Straumann Variobase for Bridge/Bar CylindricalNHA · Traditional | 07/17/2018SE |
| K173562 | Straumann Jason MembraneNPL · Traditional | 07/09/2018SE |
| K180791 | Straumann BLX Surgical CassetteKCT · Traditional | 06/21/2018SE |
| K173961 | Straumann BLX Implant SystemDZE · Traditional | 06/05/2018SE |
| K173379 | Straumann Variobase for Crown ASNHA · Traditional | 03/30/2018SE |
| K171649 | Straumann CARES M-Series CAD/CAM SystemNHA · Traditional | 02/22/2018SE |
| K172798 | Straumann CARES Abutments CoCrNHA · Traditional | 01/03/2018SE |
| K171773 | Straumann n!ce Glass Ceramic A14 BlocksNHA · Traditional | 12/01/2017SE |
| K173410 | n!ce for PlanmillEIH · Special | 11/14/2017SE |
| K162848 | Straumann CARES Golden Ti/TiN AbutmentsNHA · Traditional | 09/22/2017SE |
| K170356 | Straumann Variobase AbutmentsNHA · Traditional | 06/07/2017SE |
| K170354 | Straumann Variobase AbutmentsNHA · Traditional | 06/07/2017SE |
| K162311 | Straumann PrefGelKJJ · Traditional | 03/07/2017SE |
| K170420 | n!ce Glass Ceramic Blocks for Amann GirrbachEIH · Special | 03/02/2017SE |
| K161677 | Straumann Sterile Healing SolutionNHA · Traditional | 10/07/2016SE |
| K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,EIH · Traditional | 09/16/2016SE |
| K153758 | Straumann Bone Level Tapered ImplantsDZE · Traditional | 03/23/2016SE |
| K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…NHA · Traditional | 12/21/2012SE |
| K101465 | Straumann Cares Bridge; Straumann Cares Dolder BarNHA · Traditional | 12/13/2010SE |
| K091701 | Straumann Modified Dental AbutmentNHA · Traditional | 12/22/2009SE |
| K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentNHA · Traditional | 12/18/2009SE |
| K082111 | Straumann MembragelNPK · Traditional | 05/22/2009SE |
| K081419 | Straumann Dental Implant SystemDZE · Traditional | 02/20/2009SE |
| K082545 | Straumann NN Cares Titanium and Ceramic AbutmentsNHA · Traditional | 10/17/2008SE |
| K082764 | Straumann WN Cares Titanium AbutmentNHA · Special | 10/01/2008SE |
| K081186 | Concave RN Healing CapNHA · Special | 05/23/2008SE |
| K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsNHA · Special | 05/02/2008SE |
| K072679 | P.004 AbutmentsNHA · Special | 10/12/2007SE |
| K072497 | P.004 NC Gold Abutment for CrownsNHA · Special | 09/26/2007SE |
| K071357 | P.004 NC Anatomic AbutmentsNHA · Traditional | 09/26/2007SE |
| K070549 | Straumann P.004 RC Gold AbutmentNHA · Traditional | 08/31/2007SE |
| K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsNHA · Special | 08/15/2007SE |
| K070744 | Narrow Neck Temporary CopingNHA · Traditional | 06/29/2007SE |
| K062129 | P.0004 ImplantsDZE · Special | 10/20/2006SE |
| K061176 | Straumann Dental ImplantsDZE · Special | 08/11/2006SE |
| K053088 | Slactive ImplantsDZE · Traditional | 02/27/2006SE |
| K060062 | Straumann OrthosystemOAT · Special | 02/03/2006SE |
| K051717 | RN Synocta Temporary Meso AbutmentNHA · Special | 07/07/2005SE |
| K033984 | Straumann Dental Implant SystemDZE · Traditional | 06/30/2004SE |
| K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantNHA · Special | 05/24/2004SE |
| K040539 | Elliptic MatrixNHA · Special | 03/18/2004SE |
| K033922 | Modification to Iti Dental Implant SystemDZE · Special | 01/07/2004SE |
| K020096 | Esthetic Ease Abutments for the Iti Dental Implant SystemDZE · Special | 02/08/2002SE |
| K013891 | Synocta Angled Abutments for the Iti Wide Neck ImplantDZE · Special | 02/05/2002SE |
| K013798 | Prosthetic Accessories to the Iti Dental Implant SystemDZE · Traditional | 12/19/2001SE |
| K011698 | Straumann GBR SystemJEY · Traditional | 08/23/2001SE |
| K003552 | Iti Dental Implant SystemDZE · Traditional | 08/17/2001SE |
| K003271 | Modification to Iti Dental Implant SystemDZE · Traditional | 03/20/2001SE |
| K983742 | Iti Dental Implant SystemDZE · Traditional | 03/15/1999SE |
| K894595 | Bonefit R Screw ImplantsDZE · Traditional | 02/13/1990SE |
| K894594 | Bonefit Hollow Screw ImplantsDZE · Traditional | 02/13/1990SE |
| K894593 | Bonefit Hollow Cylinder ImplantsDZE · Traditional | 02/13/1990SE |