Not currently registered with FDA under this name
Straumann USA, LLC (On Behalf of Institut Straumann Ag)
Andover, MA, United States. Named as applicant on 3 dental 510(k) clearances between 2017 and 2020. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32017–2020
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Straumann USA, LLC (On Behalf of Institut Straumann Ag) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Aug 2020 | K200597 | Straumann BLX Gold Abutments | NHA Endosseous Dental Implant Abutment |
| 27 Nov 2017 | K171757 | Straumann Screw Retained Abutments | NHA Endosseous Dental Implant Abutment |
| 14 Nov 2017 | K171769 | Straumann PURE Ceramic Implants | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Institut Straumann AG (2).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.