# Straumann USA

- Location (FDA's records): Andover, MA
- FDA decisions: 66 (1996–2024): 66 510(k) clearances
- Names in FDA's records: Straumann USA (41); Straumann USA, LLC (24); Straumann USA, Inc. (1)
- Product codes: NHA (31), DZE (27), LLZ (1), KCT (1), ELB (1), OAT (1), DZI (1), DZL (1), KJJ (1), KCZ (1)
- 510(k) review time since 2016: median 216 days, against 200 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 178 (70 its own); citations of its devices by later devices: 245 (70 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Institut Straumann AG: 58 (https://510kreport.com/company/institut-straumann)
- Straumann Manufacturing, Inc.: 6 (https://510kreport.com/company/straumann-manufacturing)
- Straumann Institute, Ltd.: 5 (https://510kreport.com/company/straumann-institute)
- The Straumann Co.: 5 (https://510kreport.com/company/straumann)
- Nobelpharma USA, Inc.: 5 (https://510kreport.com/company/nobelpharma-usa)
- Nobel Biocare AB: 4 (https://510kreport.com/company/nobel-biocare)
- Implant Innovations, Inc.: 3 (https://510kreport.com/company/implant-innovations)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)

## Firms that cite its devices most
- Institut Straumann AG: 52 (https://510kreport.com/company/institut-straumann)
- Terrats Medical SL: 6 (https://510kreport.com/company/terrats-medical)
- Jjgc Industria E Comercio DE Materiais Dentarios S: 4 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios-s)
- Sulzer Dental, Inc.: 4 (https://510kreport.com/company/sulzer-dental)
- T.F.I. System S.R.L: 4 (https://510kreport.com/company/tfi-system)
- Straumann USA, LLC (On Behalf of Institut Straumann Ag): 4 (https://510kreport.com/company/straumann-usa-on-behalf-of-institut-straumann)
- Straumann Manufacturing, Inc.: 4 (https://510kreport.com/company/straumann-manufacturing)
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.: 4 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios)

## Its most-cited devices
- K990342: Synocta Prosthetics (1999), cited by 14
- K030007: Iti Dental Implant System (2003), cited by 12
- K012757: Iti Dental Implant System (2001), cited by 11
- K984104: Iti Dental Implant System (1999), cited by 10
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw (2014), cited by 10
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System (2002), cited by 9

## Recent decisions
- K241575: Straumann® Anatomic Healing Abutments XC (AHA) (Nov 11, 2024)
- K203753: Straumann Surgical Cassettes (Jul 29, 2021)
- K202942: Straumann 4 mm Short Implants (Feb 8, 2021)
- K192401: Straumann Screw-Retained Abutments (Apr 6, 2020)
- K190662: MRI Compatibility for Existing Straumann Dental Implant Systems (Jun 17, 2019)
- K171784: Straumann Dental Implant System (Jan 19, 2018)
- K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (Mar 8, 2017)
- K151590: Straumann RN Gold Abutment for Bridge (Mar 4, 2016)

Source page: https://510kreport.com/company/straumann-usa