Medical Device Manufacturer · CH , Basel

Institut Straumann AG

88 submissions · 88 cleared · Since 1990
88
Total
88
Cleared
0
Denied

Institut Straumann AG — FDA 510(k) Submissions

Institut Straumann AG has submitted 88 FDA 510(k) premarket notifications since 1990, of which 88 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Abutment, Implant, Dental, Endosseous, Implant, Endosseous, Root-form, Powder, Porcelain, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Bone Grafting Material, Animal Source . Use the specialty filter in the sidebar to narrow results.

88 devices
1–25 of 88
Straumann? BLC Implants - Indication Widening
K252168 · DZE Implant, Endosseous,... · Dental
Mar 2026 243d
Straumann Variobase Abutments XC for Bridge/Bar
K253315 · NHA Abutment, Implant,... · Dental
Jan 2026 114d
Straumann? RidgeFit Implants
K250294 · DZE Implant, Endosseous,... · Dental
Aug 2025 193d
Custom Abutments
K243278 · NHA Abutment, Implant,... · Dental
Feb 2025 128d
Straumann InLab Validated Workflow
K243478 · NHA Abutment, Implant,... · Dental
Feb 2025 103d
Straumann CARES Visual and Nova Dental CAD
K233252 · PNP Dental Abutment Design... · Dental
Dec 2024 455d
Straumann? PURE Ceramic Implants
K241391 · DZE Implant, Endosseous,... · Dental
Dec 2024 209d
Straumann? BLC and TLC Implants - Line extension
K234049 · DZE Implant, Endosseous,... · Dental
Mar 2024 90d
Straumann? BLC and TLC Implants
K230108 · DZE Implant, Endosseous,... · Dental
Sep 2023 244d
Straumann SLActive labeling changes
K223083 · DZE Implant, Endosseous,... · Dental
Jun 2023 265d
Straumann? Variobase? Abutments and Straumann? n!ce? Zirconia discs
K222836 · NHA Abutment, Implant,... · Dental
May 2023 237d
Straumann TLX Variobase C
K220878 · NHA Abutment, Implant,... · Dental
Jun 2022 83d
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751 · NHA Abutment, Implant,... · Dental
Jun 2022 79d
TLX SRAs and TLX Gold Abutments
K213063 · NHA Abutment, Implant,... · Dental
Apr 2022 197d
BLX WB ?5.0 (L18), ?5.5 and ?6.5 mm (L14 and L16) Implants
K212533 · DZE Implant, Endosseous,... · Dental
Jan 2022 170d
Straumann CARES P-Series CAD/CAM System
K203750 · NHA Abutment, Implant,... · Dental
Oct 2021 290d
Straumann RidgeFit Implants
K211052 · DZE Implant, Endosseous,... · Dental
Jul 2021 90d
Straumann CARES M-Series CAD/CAM System
K203456 · NHA Abutment, Implant,... · Dental
Jun 2021 212d
Straumann BLX Implant System
K210855 · DZE Implant, Endosseous,... · Dental
Jun 2021 90d
Straumann Immediate Temporary Abutments
K201681 · NHA Abutment, Implant,... · Dental
Mar 2021 269d
Straumann Variobase C
K192742 · NHA Abutment, Implant,... · Dental
Feb 2021 501d
Straumann TLX Novaloc and Cementable Abutments
K203355 · NHA Abutment, Implant,... · Dental
Feb 2021 88d
Straumann BoneCeramic
K201051 · LYC Bone Grafting Material,... · Dental
Sep 2020 156d
Straumann TLX Implant System
K200586 · DZE Implant, Endosseous,... · Dental
Aug 2020 167d
Straumann? Retentive System ? Novaloc TiN Abutments
K193046 · NHA Abutment, Implant,... · Dental
Aug 2020 286d

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