# Straumann USA, LLC (On Behalf of Institut Straumann Ag)

- Location (FDA's records): Andover, MA
- FDA decisions: 5 (2007–2020): 5 510(k) clearances
- Names in FDA's records: Straumann USA, LLC (On Behalf of Institut Straumann Ag) (3); Straumann USA (On Behalf of Institut Straumann Ag) (2)
- Product codes: NHA (3), NPK (1), DZE (1)
- 510(k) review time since 2016: median 163 days, against 188 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Institut Straumann AG: 5 (https://510kreport.com/company/institut-straumann)
- Straumann USA: 4 (https://510kreport.com/company/straumann-usa)
- Straumann Institute, Ltd.: 1 (https://510kreport.com/company/straumann-institute)

## Firms that cite its devices most
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Medentika GmbH: 1 (https://510kreport.com/company/medentika)

## Its most-cited devices
- K171769: Straumann PURE Ceramic Implants (2017), cited by 2
- K171757: Straumann Screw Retained Abutments (2017), cited by 2

## Recent decisions
- K200597: Straumann BLX Gold Abutments (Aug 19, 2020)
- K171757: Straumann Screw Retained Abutments (Nov 27, 2017)
- K171769: Straumann PURE Ceramic Implants (Nov 14, 2017)
- K101956: Straumann Membragel (Dec 16, 2010)
- K071919: P.004 Abutments (Sep 26, 2007)

Source page: https://510kreport.com/company/straumann-usa-on-behalf-of-institut-straumann