Straumann USA, LLC (On Behalf of Institut Straumann AG)
Country not established
- Devices
- 5
What Straumann USA, LLC (On Behalf of Institut Straumann AG) makes
Straumann USA, LLC manufactures dental implants and abutments, including titanium-based BLX Gold abutments and ceramic PURE implants designed for dental restoration. Their portfolio also includes screw-retained abutments for securing prosthetic crowns in implant-supported dentistry.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates under Institut Straumann AG and is based in the United States.
Catalogue
P.004 Abutments Ref K071919
Regimes: 510(k) Registry: 510(k)Straumann Membragel Ref K101956
Regimes: 510(k) Registry: 510(k)Straumann BLX Gold Abutments Ref K200597
Regimes: 510(k) Registry: 510(k)Straumann PURE Ceramic Implants Ref K171769
Regimes: 510(k) Registry: 510(k)Straumann Screw Retained Abutments Ref K171757
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Straumann USA, LLC (On Behalf of Institut Straumann Ag) have in the registry?
The registry currently lists 5 devices for Straumann USA, LLC (On Behalf of Institut Straumann Ag). Devices recorded under merged duplicate company entries are counted once.
Which registries list Straumann USA, LLC (On Behalf of Institut Straumann Ag)'s devices?
Among its 5 most recently registered devices, Straumann USA, LLC (On Behalf of Institut Straumann Ag) has devices listed in FDA 510(k) (5 devices).
What risk classes do Straumann USA, LLC (On Behalf of Institut Straumann Ag)'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Straumann USA, LLC (On Behalf of Institut Straumann Ag)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Straumann USA, LLC (On Behalf of Institut Straumann Ag) in the registry?
The most recently registered devices listed for Straumann USA, LLC (On Behalf of Institut Straumann Ag) include P.004 ABUTMENTS, STRAUMANN MEMBRAGEL, Straumann BLX Gold Abutments and Straumann PURE Ceramic Implants.