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
- Manufacturer documentationStraumann Group Annual Report 2025 — Straumann Holding AG. 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 'JJGC' (Neodent) (23 records since 2010) — 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 iEXCEL™ system (product page) — Institut Straumann AG. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K180536 — Neodent Implant System — GM Line — U.S. Food and Drug Administration, 2018-08-30. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K230108 — Straumann BLC and TLC Implants (510(k) summary) — U.S. Food and Drug Administration, 2023-09-14. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K223638 — Neodent Helix Short Implant System — U.S. Food and Drug Administration, 2023-06-23. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K241391 — Straumann PURE Ceramic Implants — U.S. Food and Drug Administration, 2024-12-10. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K201491 — Neodent Zirconia Implant System — U.S. Food and Drug Administration, 2020-12-22. Accessed 28 Sep 2026.
- Manufacturer documentationStraumann® Zygomatic Implant System (product page) — Institut Straumann AG. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K232099 — Neodent GM Zygomatic Implant System — U.S. Food and Drug Administration, 2023-10-31. Accessed 28 Sep 2026.