In short
- 510(k) = 'cleared', not 'FDA approved'.
- A clearance is not a quality ranking or a comparison between brands.
- Straumann's first listed implant clearances date from 1990.
Key clearances
| System | 510(k) | Cleared |
|---|---|---|
| BLX | K1739612 | 2018 |
| TLX | K2005863 | 2020 |
| BLC & TLC | K2301084 | 2023 |
| BLC & TLC line extension | K2340495 | 2024 |
| BLC pterygoid indication | K2521686 | 2026 |
| Bone Level Tapered | K1408787 | 2014 |
| BLT Ø2.9 mm | K1628908 | 2017 |
| PURE Ceramic | K2413919 | 2024 |
| Mini Implants | K19189510 | 2019 |
| RidgeFit | K25029411 | 2025 |
| 4 mm Short Implants | K20294212 | 2021 |
| MRI compatibility (existing systems) | K19066213 | 2019 |
What 'cleared' means
Most dental implants reach the US market through the 510(k) route, in which the FDA determines that a device is substantially equivalent to one already legally marketed. The correct word is 'cleared', not 'approved'. A clearance does not rank quality or compare brands.
Straumann zygomatic implants: we found no FDA 510(k) record (checked 28 September 2026).1
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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 recordopenFDA: 510(k) clearances with applicant 'Straumann', product code DZE (69 records, 1990–2026) — U.S. Food and Drug Administration. Accessed 28 Sep 2026.
- 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) K200586 — Straumann TLX Implant System (510(k) summary) — U.S. Food and Drug Administration, 2020-08-20. 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) K234049 — Straumann BLC and TLC Implants — line extension — U.S. Food and Drug Administration, 2024-03-20. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K252168 — Straumann BLC Implants — indication widening (pterygoid) — U.S. Food and Drug Administration, 2026-03-10. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K140878 — Straumann Bone Level Tapered Implant — U.S. Food and Drug Administration, 2014-08-20. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K162890 — Straumann Ø2.9 mm Bone Level Tapered Implants — U.S. Food and Drug Administration, 2017-03-08. 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) K191895 — Straumann Mini Implants — U.S. Food and Drug Administration, 2019-12-09. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K250294 — Straumann RidgeFit Implants — U.S. Food and Drug Administration, 2025-08-12. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K202942 — Straumann 4 mm Short Implants — U.S. Food and Drug Administration, 2021-02-08. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems — U.S. Food and Drug Administration, 2019-06-17. Accessed 28 Sep 2026.
Educational information only. The choice of implant system depends on your anatomy, restorative plan, bone quality and the clinician's assessment. This website does not recommend a specific implant for you.
