Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentium Co., Ltd (Ict Branch) · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023-12-14 | 232 | 0 |
| K200270 | rainbow MCT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | 437 | 0 |
| K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | 437 | 0 |
| K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | 2020-06-10 | 30 | 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