Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Challenge Products, Inc. · 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) |
|---|---|---|---|---|---|
| K962370 | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE | Challenge Products, Inc. | 1997-03-31 | 285 | 0 |
| K940496 | PROPHY PASTE | Challenge Products, Inc. | 1994-04-19 | 76 | 0 |
| K884245 | PERFECT CHOICE | Challenge Products, Inc. | 1989-01-04 | 85 | 0 |
| K853248 | CHALLENGER SUNRISE | Challenge Products, Inc. | 1985-09-13 | 44 | 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