Not currently registered with FDA under this name
Pou YU Biotechnology Co., Ltd.
Fusing Township, Changhua Cty, Taiwan. Named as applicant on 6 dental 510(k) clearances between 2008 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 62008–2011
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Pou YU Biotechnology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Pou YU Biotechnology Co., Ltd. | 6 clearances | 2008–2011 | Below |
| Canada | Health Canada | Registration holder | POU YU BIOTECHNOLOGY CO., LTD | 2 | 2009–2010 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Pou YU Biotechnology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Mar 2011 | K103339 | TDS ABUTMENT FOR FRIADENT XIVE | NHA Endosseous Dental Implant Abutment |
| 5 Oct 2010 | K100356 | TDS PRECISION DENTAL BAR | NHA Endosseous Dental Implant Abutment |
| 30 Jul 2009 | K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | NHA Endosseous Dental Implant Abutment |
| 30 Jul 2009 | K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | NHA Endosseous Dental Implant Abutment |
| 24 Jun 2009 | K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | NHA Endosseous Dental Implant Abutment |
| 21 Nov 2008 | K081460 | TDS ABUTMENT | NHA Endosseous Dental Implant Abutment |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.