# Zirkonzahn Srl

- Location (FDA's records): Gais, IT
- FDA decisions: 11 (2006–2023): 11 510(k) clearances
- Names in FDA's records: Zirkonzahn Srl (8); Zirkonzahn GmbH (3)
- Product codes: EIH (6), EBG (2), EBI (1), LLZ (1), EBF (1)
- 510(k) review time since 2016: median 121 days, against 121 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 13 (3 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
- Union Dental S.A.: 2 (https://510kreport.com/company/union-dental)
- The Argen Corporation: 1 (https://510kreport.com/company/argen)
- Vita Zanhnfabrik H. Rauter GmbH Co.: 1 (https://510kreport.com/company/vita-zanhnfabrik-h-rauter)
- 3Diemme, Ltd.: 1 (https://510kreport.com/company/3diemme)
- Vita Zahnfabrik H.Rauter GmbH & Co.: 1 (https://510kreport.com/company/vita-zahnfabrik-h-rauter)
- Bredent GmbH & Co. KG: 1 (https://510kreport.com/company/bredent)

## Firms that cite its devices most
- Prismatik Dentalcraft, Inc.: 2 (https://510kreport.com/company/prismatik-dentalcraft)
- Amann Girrbach America, Inc.: 1 (https://510kreport.com/company/amann-girrbach-america)
- Aidite (Qinhuangdao) Technology Co., Ltd.: 1 (https://510kreport.com/company/aidite-qinhuangdao-technology)
- Dmg Chemisch Pharmazeutische Fabrik GmbH: 1 (https://510kreport.com/company/dmg-chemisch-pharmazeutische-fabrik)
- Kuraray Noritake Dental, Inc.: 1 (https://510kreport.com/company/kuraray-noritake-dental)
- Bloomden Bioceramics (HuNan) Co., Ltd.: 1 (https://510kreport.com/company/bloomden-bioceramics-hunan)
- Genoss Co., Ltd.: 1 (https://510kreport.com/company/genoss)
- Shenzhen Yurucheng Dental Materials Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-yurucheng-dental-materials)

## Its most-cited devices
- K061851: Zirkonzahn Ice (2006), cited by 6
- K183304: Prettau, ICE, Z-White zirconia blanks (2019), cited by 3
- K190518: Color Liquid, Vita Liquid (2019), cited by 2
- K180562: Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout (2018), cited by 1
- K132230: Ice Zirkon Transluzent (2014), cited by 1

## Recent decisions
- K232691: Polibond (Sep 5, 2023)
- K213722: ICE Ceramics, ICE Stains, Fresco (Dec 14, 2022)
- K203765: ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray (Jul 20, 2021)
- K200676: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA (Jul 8, 2020)
- K190518: Color Liquid, Vita Liquid (Nov 22, 2019)
- K183304: Prettau, ICE, Z-White zirconia blanks (Apr 4, 2019)
- K180562: Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout (Jun 28, 2018)
- K181484: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue (Jun 18, 2018)

Source page: https://510kreport.com/company/zirkonzahn