# Institut Straumann AG

- Location (FDA's records): Basel, CH
- FDA decisions: 92 (1990–2026): 92 510(k) clearances
- Names in FDA's records: Institut Straumann AG (90); Institut Straumann SA (2)
- Product codes: NHA (47), DZE (31), KCT (3), EIH (3), NPM (1), JEY (1), LYC (1), PNP (1), KJJ (1), NPK (1), NPL (1), OAT (1)
- 510(k) review time since 2016: median 155 days, against 188 for FDA's reviews in the same codes and years (35 of 53 faster)
- Predicates its devices cite: 157 (60 its own); citations of its devices by later devices: 223 (60 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Straumann USA: 52 (https://510kreport.com/company/straumann-usa)
- The Straumann Co.: 8 (https://510kreport.com/company/straumann)
- Nobel Biocare AB: 5 (https://510kreport.com/company/nobel-biocare)
- Implant Innovations, Inc.: 3 (https://510kreport.com/company/implant-innovations)
- Metoxit AG: 3 (https://510kreport.com/company/metoxit)
- Friadent GmbH: 3 (https://510kreport.com/company/friadent)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Straumann USA: 58 (https://510kreport.com/company/straumann-usa)
- Jjgc Industria E Comercio DE Materiais Dentarios S: 5 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios-s)
- Straumann USA, LLC (On Behalf of Institut Straumann Ag): 5 (https://510kreport.com/company/straumann-usa-on-behalf-of-institut-straumann)
- Medentika GmbH: 4 (https://510kreport.com/company/medentika)
- Northern Implants, LLC: 4 (https://510kreport.com/company/northern-implants)
- Straumann Manufacturing, Inc.: 4 (https://510kreport.com/company/straumann-manufacturing)
- Osstem Implant Co., Ltd.: 4 (https://510kreport.com/company/osstem-implant)
- Proimtech Saglik Urunleri Anonim Sirketi: 3 (https://510kreport.com/company/proimtech-saglik-urunleri-anonim-sirketi)

## Its most-cited devices
- K062129: P.0004 Implants (2006), cited by 31
- K033984: Straumann Dental Implant System (2004), cited by 15
- K033922: Modification to Iti Dental Implant System (2004), cited by 10
- K053088: Slactive Implants (2006), cited by 10
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), cited by 9
- K041295: RN Synocta Ucla Gold Abutment for the Straumann Dental Implant (2004), cited by 8

## Recent decisions
- K260726: Straumann® ProClean™ Cassette (041.800 ; 041.801) (Jun 3, 2026)
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (May 7, 2026)
- K252168: Straumann® BLC Implants - Indication Widening (Mar 10, 2026)
- K253315: Straumann Variobase Abutments XC for Bridge/Bar (Jan 22, 2026)
- K250294: Straumann® RidgeFit Implants (Aug 12, 2025)
- K243278: Custom Abutments (Feb 21, 2025)
- K243478: Straumann InLab Validated Workflow (Feb 19, 2025)
- K233252: Straumann CARES Visual and Nova Dental CAD (Dec 26, 2024)

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