# Biodenta Swiss AG

- Location (FDA's records): Berneck, St.Gallen, CH
- FDA decisions: 11 (2010–2015): 11 510(k) clearances
- Product codes: NHA (5), DZE (5), EIH (1)
- Predicates its devices cite: 32 (9 its own); citations of its devices by later devices: 12 (9 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: 4 (https://510kreport.com/company/nobel-biocare)
- Pou YU Biotechnology Co., Ltd.: 3 (https://510kreport.com/company/pou-yu-biotechnology)
- Prismatik Dentalcraft, Inc.: 3 (https://510kreport.com/company/prismatik-dentalcraft)
- Keystone Dental, Inc.: 2 (https://510kreport.com/company/keystone-dental)
- Mis - Implant Technologies, Ltd.: 2 (https://510kreport.com/company/mis-implant-technologies)
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- Friadent GmbH: 1 (https://510kreport.com/company/friadent)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)

## Firms that cite its devices most
- Modern Dental Laboratory (Dg) Co., Ltd.: 1 (https://510kreport.com/company/modern-dental-laboratory-dg)
- Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG: 1 (https://510kreport.com/company/argon-med-productions-vertriebs-gesellschaft-mbh)
- BioHorizons Implant Systems, Inc.: 1 (https://510kreport.com/company/biohorizons-implant-systems)

## Its most-cited devices
- K111003: Biodenta Dental Implant System - Bone Level (2011), cited by 4
- K123491: Biodenta Dental Implant System - Multi-Use Abutment (2013), cited by 2
- K110778: Biodenta Customized Abutment (2011), cited by 1
- K093630: Biodenta Dental Implant System (2010), cited by 1
- K123415: Biodenta Dental Implant System- Bone Level Tapered (2013), cited by 1
- K123512: Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM (2013), cited by 1

## Recent decisions
- K151295: Biodenta Customized Abutment - Titanium (Dec 1, 2015)
- K150296: Biodenta Customized Abutment-Hybrid (Jul 2, 2015)
- K133884: Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MM (Jun 13, 2014)
- K123491: Biodenta Dental Implant System - Multi-Use Abutment (May 30, 2013)
- K122559: Biodenta Dental Implant System - Abutments (May 3, 2013)
- K123512: Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM (Mar 28, 2013)
- K123415: Biodenta Dental Implant System- Bone Level Tapered (Mar 19, 2013)
- K111003: Biodenta Dental Implant System - Bone Level (Sep 15, 2011)

Source page: https://510kreport.com/company/biodenta-swiss