Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Green Dent. Mfg, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033044 | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER | American Green Dent. Mfg, Inc. | 2004-12-21 | 449 | 0 |
| K033045 | DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, | American Green Dent. Mfg, Inc. | 2003-12-23 | 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