Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Institut Straumann AG — Predicate Candidate Screening
90 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
283 days90th percentile
90clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 | 90 | 0 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutment | Institut Straumann AG | 2026-05-07 | 85 | 0 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 | 243 | 0 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 | 114 | 0 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 | 193 | 0 |
| K243278 | Custom Abutments | Institut Straumann AG | 2025-02-21 | 128 | 1 |
| K243478 | Straumann InLab Validated Workflow | Institut Straumann AG | 2025-02-19 | 103 | 0 |
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | 2024-12-26 | 455 | 0 |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024-12-10 | 209 | 0 |
| K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG | 2024-03-20 | 90 | 0 |
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023-09-14 | 244 | 0 |
| K223083 | Straumann SLActive labeling changes | Institut Straumann AG | 2023-06-22 | 265 | 0 |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconi | Institut Straumann AG | 2023-05-15 | 237 | 1 |
| K220878 | Straumann TLX Variobase C | Institut Straumann AG | 2022-06-16 | 83 | 0 |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022-06-02 | 79 | 0 |
| K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022-04-08 | 197 | 0 |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG | 2022-01-28 | 170 | 0 |
| K203750 | Straumann CARES P-Series CAD/CAM System | Institut Straumann AG | 2021-10-09 | 290 | 0 |
| K211052 | Straumann RidgeFit Implants | Institut Straumann AG | 2021-07-08 | 90 | 0 |
| K203456 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2021-06-23 | 212 | 0 |
| K210855 | Straumann BLX Implant System | Institut Straumann AG | 2021-06-21 | 90 | 0 |
| K201681 | Straumann Immediate Temporary Abutments | Institut Straumann AG | 2021-03-18 | 269 | 0 |
| K192742 | Straumann Variobase C | Institut Straumann AG | 2021-02-12 | 501 | 0 |
| K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | 2021-02-12 | 88 | 0 |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020-09-24 | 156 | 0 |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020-08-20 | 167 | 0 |
| K193046 | Straumann® Retentive System – Novaloc TiN Abutments | Institut Straumann AG | 2020-08-13 | 286 | 0 |
| K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020-01-03 | 84 | 0 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | 2019-12-27 | 231 | 0 |
| K191895 | Straumann Mini Implants | Institut Straumann AG | 2019-12-09 | 147 | 0 |
| K191522 | Straumann Modular Cassette | Institut Straumann AG | 2019-12-03 | 176 | 0 |
| K192029 | Straumann PUREloc abutments | Institut Straumann AG | 2019-10-28 | 90 | 0 |
| K190654 | Straumann CI RD Ceramic Healing Caps | Institut Straumann AG | 2019-06-28 | 106 | 0 |
| K190097 | Straumann CARES Screw-Retained Bridges and Bars | Institut Straumann AG | 2019-06-26 | 155 | 0 |
| K190082 | Straumann BLX Variobase Abutment | Institut Straumann AG | 2019-04-17 | 90 | 0 |
| K190040 | Straumann BLX Line Extension - New Abutments | Institut Straumann AG | 2019-04-08 | 90 | 0 |
| K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019-01-04 | 316 | 0 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic A | Institut Straumann AG | 2018-12-28 | 184 | 0 |
| K173594 | Straumann cerabone | Institut Straumann AG | 2018-10-19 | 332 | 0 |
| K173945 | Straumann SC Variobase Abutments | Institut Straumann AG | 2018-10-05 | 283 | 0 |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | Institut Straumann AG | 2018-07-17 | 200 | 0 |
| K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018-07-09 | 234 | 0 |
| K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018-06-21 | 86 | 0 |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018-06-05 | 159 | 0 |
| K173379 | Straumann Variobase for Crown AS | Institut Straumann AG | 2018-03-30 | 151 | 0 |
| K171649 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2018-02-22 | 262 | 0 |
| K172798 | Straumann CARES Abutments CoCr | Institut Straumann AG | 2018-01-03 | 107 | 0 |
| K171773 | Straumann n!ce Glass Ceramic A14 Blocks | Institut Straumann AG | 2017-12-01 | 170 | 0 |
| K173410 | n!ce for Planmill | Institut Straumann AG | 2017-11-14 | 13 | 0 |
| K162848 | Straumann CARES Golden Ti/TiN Abutments | Institut Straumann AG | 2017-09-22 | 346 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda