Company · CH
Institut Straumann AG
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2026. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 47 |
| DZE | Implant, Endosseous, Root-Form | 31 |
| EIH | Powder, Porcelain | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 |
| JEY | Plate, Bone | 1 |
| KJJ | Cleanser, Root Canal | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
| NPK | Barrier, Synthetic, Intraoral | 1 |
| NPL | Barrier, Animal Source, Intraoral | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2026 | K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) Institut Straumann AG, CH | KCT |
| May 7, 2026 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue Institut Straumann AG, CH | NHA |
| Mar 10, 2026 | K252168 | Straumann® BLC Implants - Indication Widening Institut Straumann AG, CH | DZE |
| Jan 22, 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar Institut Straumann AG, CH | NHA |
| Aug 12, 2025 | K250294 | Straumann® RidgeFit Implants Institut Straumann AG, CH | DZE |
| Feb 21, 2025 | K243278 | Custom Abutments Institut Straumann AG, CH | NHA |
| Feb 19, 2025 | K243478 | Straumann InLab Validated Workflow Institut Straumann AG, CH | NHA |
| Dec 26, 2024 | K233252 | Straumann CARES Visual and Nova Dental CAD Institut Straumann AG, CH | PNP |
| Dec 10, 2024 | K241391 | Straumann® PURE Ceramic Implants Institut Straumann AG, CH | DZE |
| Mar 20, 2024 | K234049 | Straumann® BLC and TLC Implants - Line extension Institut Straumann AG, CH | DZE |
| Sep 14, 2023 | K230108 | Straumann® BLC and TLC Implants Institut Straumann AG, CH | DZE |
| Jun 22, 2023 | K223083 | Straumann SLActive labeling changes Institut Straumann AG, CH | DZE |
| May 15, 2023 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs Institut Straumann AG, CH | NHA |
| Jun 16, 2022 | K220878 | Straumann TLX Variobase C Institut Straumann AG, CH | NHA |
| Jun 2, 2022 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA Institut Straumann AG, CH | NHA |
| Apr 8, 2022 | K213063 | TLX SRAs and TLX Gold Abutments Institut Straumann AG, CH | NHA |
| Jan 28, 2022 | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants Institut Straumann AG, CH | DZE |
| Oct 9, 2021 | K203750 | Straumann CARES P-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Jul 8, 2021 | K211052 | Straumann RidgeFit Implants Institut Straumann AG, CH | DZE |
| Jun 23, 2021 | K203456 | Straumann CARES M-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Jun 21, 2021 | K210855 | Straumann BLX Implant System Institut Straumann AG, CH | DZE |
| Mar 18, 2021 | K201681 | Straumann Immediate Temporary Abutments Institut Straumann AG, CH | NHA |
| Feb 12, 2021 | K203355 | Straumann TLX Novaloc and Cementable Abutments Institut Straumann AG, CH | NHA |
| Feb 12, 2021 | K192742 | Straumann Variobase C Institut Straumann AG, DE | NHA |
| Sep 24, 2020 | K201051 | Straumann BoneCeramic Institut Straumann AG, CH | LYC |
| Aug 20, 2020 | K200586 | Straumann TLX Implant System Institut Straumann AG, CH | DZE |
| Aug 13, 2020 | K193046 | Straumann® Retentive System Novaloc TiN Abutments Institut Straumann AG, CH | NHA |
| Jan 3, 2020 | K192893 | Straumann Ceramic Healing Abutments Institut Straumann AG, CH | NHA |
| Dec 27, 2019 | K191256 | Straumann BLX Ø3.5 mm Implants Institut Straumann AG, CH | DZE |
| Dec 9, 2019 | K191895 | Straumann Mini Implants Institut Straumann AG, CH | DZE |
| Dec 3, 2019 | K191522 | Straumann Modular Cassette Institut Straumann AG, CH | KCT |
| Oct 28, 2019 | K192029 | Straumann PUREloc abutments Institut Straumann AG, CH | NHA |
| Jun 28, 2019 | K190654 | Straumann CI RD Ceramic Healing Caps Institut Straumann AG, CH | NHA |
| Jun 26, 2019 | K190097 | Straumann CARES Screw-Retained Bridges and Bars Institut Straumann AG, CH | NHA |
| Apr 17, 2019 | K190082 | Straumann BLX Variobase Abutment Institut Straumann AG, CH | NHA |
| Apr 8, 2019 | K190040 | Straumann BLX Line Extension - New Abutments Institut Straumann AG, CH | NHA |
| Jan 4, 2019 | K180477 | Straumann PURE Ceramic Implant System Institut Straumann AG, CH | DZE |
| Dec 28, 2018 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments Institut Straumann AG, CH | DZE |
| Oct 19, 2018 | K173594 | Straumann cerabone Institut Straumann AG, CH | NPM |
| Oct 5, 2018 | K173945 | Straumann SC Variobase Abutments Institut Straumann AG, CH | NHA |
| Jul 17, 2018 | K173968 | Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG, DE | NHA |
| Jul 9, 2018 | K173562 | Straumann Jason Membrane Institut Straumann AG, CH | NPL |
| Jun 21, 2018 | K180791 | Straumann BLX Surgical Cassette Institut Straumann AG, CH | KCT |
| Jun 5, 2018 | K173961 | Straumann BLX Implant System Institut Straumann AG, CH | DZE |
| Mar 30, 2018 | K173379 | Straumann Variobase for Crown AS Institut Straumann AG, DE | NHA |
| Feb 22, 2018 | K171649 | Straumann CARES M-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Jan 3, 2018 | K172798 | Straumann CARES Abutments CoCr Institut Straumann AG, CH | NHA |
| Dec 1, 2017 | K171773 | Straumann n!ce Glass Ceramic A14 Blocks Institut Straumann AG, CH | NHA |
| Nov 14, 2017 | K173410 | n!ce for Planmill Institut Straumann AG, CH | EIH |
| Sep 22, 2017 | K162848 | Straumann CARES Golden Ti/TiN Abutments Institut Straumann AG, CH | NHA |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||