Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pou YU Biotechnology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
235 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103339 | TDS ABUTMENT FOR FRIADENT XIVE | Pou YU Biotechnology Co., Ltd. | 2011-03-31 | 136 | 0 |
| K100356 | TDS PRECISION DENTAL BAR | Pou YU Biotechnology Co., Ltd. | 2010-10-05 | 235 | 0 |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Pou YU Biotechnology Co., Ltd. | 2009-07-30 | 80 | 0 |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Pou YU Biotechnology Co., Ltd. | 2009-07-30 | 50 | 0 |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | Pou YU Biotechnology Co., Ltd. | 2009-06-24 | 75 | 0 |
| K081460 | TDS ABUTMENT | Pou YU Biotechnology Co., Ltd. | 2008-11-21 | 182 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda