Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentatus USA , 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) |
|---|---|---|---|---|---|
| K042931 | TUF LINK SILICONE RELINER | Dentatus USA , Ltd. | 2004-12-08 | 47 | 0 |
| K031793 | DENTATUS OSCIOMAT | Dentatus USA , Ltd. | 2003-11-13 | 156 | 0 |
| K980620 | DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SY | Dentatus USA , Ltd. | 1998-05-15 | 86 | 0 |
| K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA , Ltd. | 1996-07-26 | 85 | 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