# Z-Systems AG

- Location (FDA's records): Oensingen, CH
- FDA decisions: 9 (2007–2021): 9 510(k) clearances
- Product codes: DZE (8), KCT (1)
- 510(k) review time since 2016: median 250 days, against 230 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 29 (12 its own); citations of its devices by later devices: 20 (12 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
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- Oral Iceberg S.L.: 2 (https://510kreport.com/company/oral-iceberg)
- Imtec Corp.: 2 (https://510kreport.com/company/imtec)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Contour Healer, LLC: 1 (https://510kreport.com/company/contour-healer)
- Zimmer Dental, Inc.: 1 (https://510kreport.com/company/zimmer-dental)
- Intra-Lock International: 1 (https://510kreport.com/company/intra-lock-international)
- Implant Direct, LLC: 1 (https://510kreport.com/company/implant-direct)

## Firms that cite its devices most
- Oral Iceberg S.L.: 1 (https://510kreport.com/company/oral-iceberg)
- Infinitum Eta, Ltd.: 1 (https://510kreport.com/company/infinitum-eta)
- Talladium España, SL: 1 (https://510kreport.com/company/talladium-espana)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Tav Medical, Ltd.: 1 (https://510kreport.com/company/tav-medical)
- Coho Technology Co., Ltd.: 1 (https://510kreport.com/company/coho-technology)
- Ziterion: 1 (https://510kreport.com/company/ziterion)
- Dentalpoint AG: 1 (https://510kreport.com/company/dentalpoint)

## Its most-cited devices
- K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX (2007), cited by 6
- K120793: Z-LOOK3 Evo SLM (2012), cited by 5
- K132881: Z5C (2014), cited by 4
- K190243: Z5-BL (2020), cited by 2
- K201878: ST-Z5 (2021), cited by 2
- K131701: Z5MLB, Z5MLC (2013), cited by 1

## Recent decisions
- K201878: ST-Z5 (Mar 25, 2021)
- K201712: Z5-TL (Dec 1, 2020)
- K200386: Z5-BL (Oct 14, 2020)
- K190243: Z5-BL (Jan 3, 2020)
- K150021: Z5m (t) (Jul 31, 2015)
- K132881: Z5C (Jul 3, 2014)
- K131701: Z5MLB, Z5MLC (Sep 5, 2013)
- K120793: Z-LOOK3 Evo SLM (Dec 21, 2012)

Source page: https://510kreport.com/company/z-systems