Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shinhung Mst Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
387 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221752 | Stella | Shinhung Mst Co., Ltd. | 2023-06-04 | 353 | 0 |
| K223395 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2023-02-03 | 87 | 0 |
| K221317 | S-Mono | Shinhung Mst Co., Ltd. | 2023-01-13 | 252 | 0 |
| K200189 | Luna Dental Implant System- Healing Abutment | Shinhung Mst Co., Ltd. | 2020-02-26 | 30 | 0 |
| K162867 | MagDen Dental Implant System | Shinhung Mst Co., Ltd. | 2017-07-26 | 286 | 0 |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2016-08-26 | 220 | 0 |
| K123155 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2013-10-31 | 387 | 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