Shinhung Mst Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shinhung Mst Co., Ltd.” (first 2013, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 252 days. Since 2017 the median was 252 days, against 191 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 |
|---|---|---|
| 2013 | 1 | 387 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 220 |
| 2017 | 1 | 286 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 252 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shinhung Mst Co., Ltd. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
Review panels
- Dental (7)
Most recent Shinhung Mst Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221752 | Stella | DZE | 2023-06-04 | 353 |
| K223395 | Luna Dental Implant System | NHA | 2023-02-03 | 87 |
| K221317 | S-Mono | DZE | 2023-01-13 | 252 |
| K200189 | Luna Dental Implant System- Healing Abutment | NHA | 2020-02-26 | 30 |
| K162867 | MagDen Dental Implant System | DZE | 2017-07-26 | 286 |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | DZE | 2016-08-26 | 220 |
| K123155 | LUNA DENTAL IMPLANT SYSTEM | DZE | 2013-10-31 | 387 |
Recalls
openFDA lists no recalls under a recalling firm named Shinhung Mst 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.
- Shinhung Company, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shinhung Mst Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Shinhung Mst Co., Ltd.” (first 2013, latest 2023), across 2 product codes 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 Shinhung Mst Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shinhung Mst Co., Ltd. is 252 days. Since 2017: 252 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shinhung Mst Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5); NHA (Abutment, Implant, Dental, Endosseous, 2).
Next steps
- See all 7 Shinhung Mst Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Shinhung Mst 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.