# Pou YU Biotechnology Co., Ltd.

- Location (FDA's records): Fusing Township, Changhua Cty, TW
- FDA decisions: 6 (2008–2011): 6 510(k) clearances
- Product codes: NHA (6)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 10 (0 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
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- Cagenix, Inc.: 1 (https://510kreport.com/company/cagenix)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Friadent GmbH: 1 (https://510kreport.com/company/friadent)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)
- Atlantis Components, Inc.: 1 (https://510kreport.com/company/atlantis-components)

## Firms that cite its devices most
- National Dentex Corp: 4 (https://510kreport.com/company/national-dentex)
- Biodenta Swiss AG: 3 (https://510kreport.com/company/biodenta-swiss)
- BioHorizons Implant Systems, Inc.: 1 (https://510kreport.com/company/biohorizons-implant-systems)
- Green Dentech Co, Ltd.: 1 (https://510kreport.com/company/green-dentech)
- Creodent Prosthetics, Ltd.: 1 (https://510kreport.com/company/creodent-prosthetics)

## Its most-cited devices
- K091026: TDS Abutment for Nobel Biocare Replace (2009), cited by 4
- K103339: TDS Abutment for Friadent Xive (2011), cited by 3
- K091392: TDS Titanium Abutment for Nobel Biocare Branemark (2009), cited by 2
- K081460: TDS Abutment (2008), cited by 1

## Recent decisions
- K103339: TDS Abutment for Friadent Xive (Mar 31, 2011)
- K100356: TDS Precision Dental Bar (Oct 5, 2010)
- K091392: TDS Titanium Abutment for Nobel Biocare Branemark (Jul 30, 2009)
- K091693: TDS Zirconia Abutment for Nobel Biocare Branemark (Jul 30, 2009)
- K091026: TDS Abutment for Nobel Biocare Replace (Jun 24, 2009)
- K081460: TDS Abutment (Nov 21, 2008)

Source page: https://510kreport.com/company/pou-yu-biotechnology
