Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gresco Products, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981524 | PRILANE | Gresco Products, Inc. | 1998-07-10 | 73 | 0 |
| K913405 | KAR-D-TEK | Gresco Products, Inc. | 1991-10-28 | 90 | 0 |
| K910813 | MET-ETCH | Gresco Products, Inc. | 1991-05-07 | 70 | 0 |
| K910803 | ENAMEL ETCHING GEL | Gresco Products, Inc. | 1991-03-15 | 17 | 0 |
| K901973 | CP-3 DENTAL POLISHING MATERIAL | Gresco Products, Inc. | 1990-06-01 | 31 | 0 |
| K854495 | GRESCO N.P. DENTAL ALLOY | Gresco Products, Inc. | 1985-12-27 | 45 | 0 |
| K854494 | CERAM-ETCH | Gresco Products, Inc. | 1985-12-23 | 41 | 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