Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Megagen Co., Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
231 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2011-11-22 | 231 | 0 |
| K101890 | BALL ABUTMENT SYSTEM | Megagen Co., Ltd. | 2011-02-03 | 211 | 0 |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2008-04-11 | 164 | 0 |
| K070562 | EZ PLUS IMPLANT SYSTEM | Megagen Co., Ltd. | 2007-05-18 | 80 | 0 |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2007-04-02 | 160 | 0 |
| K053353 | RESCUE IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-04-19 | 138 | 0 |
| K053354 | INTERMEZZO PLUS FIXTURE | Megagen Co., Ltd. | 2006-04-13 | 132 | 0 |
| K052369 | EXFEEL IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-01-10 | 134 | 0 |
| K051018 | INTERMEZZO IMPLANT SYSTEMS | Megagen Co., Ltd. | 2005-09-02 | 134 | 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