# The Argen Corporation

- Location (FDA's records): San Diego, CA
- FDA decisions: 11 (2007–2024): 11 510(k) clearances
- Names in FDA's records: The Argen Corporation (6); Argen Corporation (5)
- Product codes: EIH (5), NHA (3), NXC (2), EBG (1)
- 510(k) review time since 2016: median 130 days, against 182 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 9 (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
- Merz Dental GmbH: 2 (https://510kreport.com/company/merz-dental)
- Sterngold Dental, LLC: 2 (https://510kreport.com/company/sterngold-dental)
- Vipi Industria,Comercio,Exportacao E Importacao DE: 1 (https://510kreport.com/company/vipi-industria-comercio-exportacao-e-importacao)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Nobel Biocare USA, LLC: 1 (https://510kreport.com/company/nobel-biocare-usa)
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)

## Firms that cite its devices most
- Zirkonzahn Srl: 1 (https://510kreport.com/company/zirkonzahn)
- United Zirconia: 1 (https://510kreport.com/company/united-zirconia)
- Utah Medical Products and Services: 1 (https://510kreport.com/company/utah-medical-products-and-services)
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)
- Creodent Prosthetics, Ltd.: 1 (https://510kreport.com/company/creodent-prosthetics)
- United Dental Resources Corporation: 1 (https://510kreport.com/company/united-dental-resources)

## Its most-cited devices
- K192846: Argen Clear Aligner, Argen Clear Aligner Premium (2020), cited by 2
- K182833: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer (2019), cited by 2
- K190079: ArgenZ HT+ (2019), cited by 2
- K160248: ArgenIS Titanium Abutments (2016), cited by 1
- K143051: ArgenIS Titanium Abutments (2015), cited by 1
- K183229: Argen Clear Aligner (2019), cited by 1

## Recent decisions
- K242458: ArgenZ MTZ (Oct 24, 2024)
- K192846: Argen Clear Aligner, Argen Clear Aligner Premium (Feb 10, 2020)
- K183229: Argen Clear Aligner (Jun 7, 2019)
- K190079: ArgenZ HT+ (Apr 12, 2019)
- K182833: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer (Feb 8, 2019)
- K172430: ArgenIS Titanium Abutments (May 18, 2018)
- K160248: ArgenIS Titanium Abutments (Aug 5, 2016)
- K143051: ArgenIS Titanium Abutments (Sep 16, 2015)

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