Clinical review pending. Facts on this page are checked against the sources listed below (regulatory records, manufacturer documents, peer-reviewed research). A named clinician will review it before we call it medically reviewed.
Last updated 28 Sep 2026 · How we review
Last updated 28 Sep 2026 · How we review
Sources
- Regulatory recordFDA 510(k) K173961 — Straumann BLX Implant System (510(k) summary) — U.S. Food and Drug Administration, 2018-06-05. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K121995 — TS Fixture System (Osstem) — U.S. Food and Drug Administration, 2012-11-29. Accessed 28 Sep 2026.
- Manufacturer documentationMRI Safety Information, document 702071/H/07 (05/23) — Institut Straumann AG, 2023-05. Accessed 28 Sep 2026.
- Regulatory recordopenFDA: implant 510(k)s with applicant 'Osstem' (28 records since 2005) — U.S. Food and Drug Administration (openFDA). Accessed 28 Sep 2026.
- Regulatory recordopenFDA: 510(k) clearances with applicant 'Straumann', product code DZE (69 records, 1990–2026) — U.S. Food and Drug Administration. Accessed 28 Sep 2026.
- Manufacturer documentationStraumann® BLX Implant System — Basic Information (702115) — Institut Straumann AG, 2024-11. Accessed 28 Sep 2026.