Megagen Implant Co., Ltd.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Megagen Implant Co., Ltd.” (first 2008, latest 2026), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 180 days. Since 2017 the median was 219 days, against 156 days for all cleared 510(k)s in the same product codes. 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 | 2 | 48 |
| 2013 | 3 | 142 |
| 2014 | 1 | 332 |
| 2015 | 1 | 140 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 4 | 158 |
| 2020 | 1 | 143 |
| 2021 | 3 | 267 |
| 2022 | 3 | 255 |
| 2023 | 6 | 277 |
| 2024 | 4 | 134 |
| 2025 | 1 | 186 |
| 2026 | 1 | 422 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Megagen Implant Co., Ltd. took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 17 | 17 |
| NHA | Abutment, Implant, Dental, Endosseous | 7 | 7 |
| EIA | Unit, Operative Dental | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| JEY | Plate, Bone | 1 | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
Most recent Megagen Implant Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251232 | MegaGen Zygoma Dental Implant System | DZE | 2026-06-18 | 422 |
| K242030 | MegaGen Dental Implant Abutment | NHA | 2025-01-13 | 186 |
| K241972 | BLUEDIAMOND IMPLANT | DZE | 2024-12-27 | 175 |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | NHA | 2024-09-18 | 264 |
| K240754 | N2 | EIA | 2024-03-21 | 1 |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | NHA | 2024-01-22 | 94 |
| K231967 | ARi ExCon Implant System | DZE | 2023-12-07 | 157 |
| K223909 | R2GATE Lite TM | LLZ | 2023-10-20 | 295 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | DZE | 2023-10-11 | 219 |
| K223339 | Bone Chamber Implant | DZE | 2023-07-18 | 259 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Megagen Implant 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Megagen Co., Ltd. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Megagen Implant Co., Ltd.?
FDA lists 32 510(k) clearances under the applicant name “Megagen Implant Co., Ltd.” (first 2008, latest 2026), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Megagen Implant Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Megagen Implant Co., Ltd. is 180 days. Since 2017: 219 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Megagen Implant Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 17); NHA (Abutment, Implant, Dental, Endosseous, 7); EIA (Unit, Operative Dental, 2).
Next steps
- See all 32 Megagen Implant Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Megagen Implant 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.