Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opusdent , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021508 | OPUSDUO EC DENTAL LASER SYSTEM | Opusdent , Ltd. | 2002-08-07 | 90 | 0 |
| K014100 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND | Opusdent , Ltd. | 2002-01-08 | 26 | 0 |
| K011769 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND | Opusdent , Ltd. | 2001-08-30 | 84 | 0 |
| K002899 | OPUS 20, MODEL 1ST | Opusdent , Ltd. | 2000-12-12 | 85 | 0 |
| K000990 | OPUS 10 DENTAL DIODE LASER | Opusdent , Ltd. | 2000-06-23 | 87 | 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