Megagen Co., Ltd.: FDA clearances and approvals
Megagen Co., Ltd. has 9 FDA 510(k) clearances (first 2005, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time: 138 days.
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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
Review panels
- Dental (9)
Most recent Megagen Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | DZE | 2011-11-22 | 231 |
| K101890 | BALL ABUTMENT SYSTEM | NHA | 2011-02-03 | 211 |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | DZE | 2008-04-11 | 164 |
| K070562 | EZ PLUS IMPLANT SYSTEM | NHA | 2007-05-18 | 80 |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | DZE | 2007-04-02 | 160 |
| K053353 | RESCUE IMPLANT SYSTEM | DZE | 2006-04-19 | 138 |
| K053354 | INTERMEZZO PLUS FIXTURE | DZE | 2006-04-13 | 132 |
| K052369 | EXFEEL IMPLANT SYSTEM | DZE | 2006-01-10 | 134 |
| K051018 | INTERMEZZO IMPLANT SYSTEMS | DZE | 2005-09-02 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Megagen Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Megagen Co., Ltd. have?
Megagen Co., Ltd. has 9 FDA 510(k) clearances (first 2005, latest 2011), across 2 product codes in 1 review panel.
How long does FDA take to clear Megagen Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Megagen Co., Ltd.'s cleared 510(k)s is 138 days.
What devices does Megagen Co., Ltd. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 7); NHA (Abutment, Implant, Dental, Endosseous, 2).
Has Megagen Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Megagen Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Megagen Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Megagen Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.