Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Straumann GroupLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Straumann USA with 71 510(k) clearances and 22 device recalls. The most recent is a 510(k) clearance dated Nov 11, 2024: Straumann® Anatomic Healing Abutments XC (AHA).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 11, 2024 | Straumann® Anatomic Healing Abutments XC (AHA)K241575 · NHA | 510(k) clearances |
| Jul 29, 2021 | Straumann Surgical CassettesK203753 · KCT | 510(k) clearances |
| Feb 8, 2021 | Straumann 4 mm Short ImplantsK202942 · DZE | 510(k) clearances |
| Aug 19, 2020 | Straumann BLX Gold AbutmentsK200597 · NHA | 510(k) clearances |
| Apr 6, 2020 | Straumann Screw-Retained AbutmentsK192401 · NHA | 510(k) clearances |
| Jun 17, 2019 | MRI Compatibility for Existing Straumann Dental Implant SystemsK190662 · DZE | 510(k) clearances |
| Jan 19, 2018 | Straumann Dental Implant SystemK171784 · DZE | 510(k) clearances |
| Nov 27, 2017 | Straumann Screw Retained AbutmentsK171757 · NHA | 510(k) clearances |
| Oct 27, 2014 | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.Class II · Drill set may contain incorrect drill. | Device recalls |
| Sep 24, 2014 | Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intClass II · Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) | Device recalls |
| Sep 19, 2014 | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended fClass II · Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) | Device recalls |
| Jul 11, 2012 | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: DentaClass II · Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
