Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
We Dong Myung Dental Industrial Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SA | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 | 15 | 0 |
| K033434 | BESTALOY | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 | 15 | 0 |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 | 15 | 0 |
| K030206 | APEX 90 | We Dong Myung Dental Industrial Co., Ltd. | 2003-01-29 | 8 | 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