Pou YU Biotechnology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pou YU Biotechnology Co., Ltd.” (first 2008, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
Review panels
- Dental (6)
Most recent Pou YU Biotechnology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103339 | TDS ABUTMENT FOR FRIADENT XIVE | NHA | 2011-03-31 | 136 |
| K100356 | TDS PRECISION DENTAL BAR | NHA | 2010-10-05 | 235 |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | NHA | 2009-07-30 | 50 |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | NHA | 2009-07-30 | 80 |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | NHA | 2009-06-24 | 75 |
| K081460 | TDS ABUTMENT | NHA | 2008-11-21 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Pou YU Biotechnology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pou YU Biotechnology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Pou YU Biotechnology Co., Ltd.” (first 2008, latest 2011), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pou YU Biotechnology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pou YU Biotechnology Co., Ltd. is 108 days.
Which FDA product codes appear under Pou YU Biotechnology Co., Ltd.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 6).
Next steps
- See all 6 Pou YU Biotechnology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Pou YU Biotechnology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.