Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOT · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
186 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | 1994-12-20 | 43 | 0 |
| K941365 | MPI DENTURE ADHESIVE FILM SEALS | Medical Polymers, Inc. | 1994-04-22 | 32 | 0 |
| K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | 1990-10-24 | 78 | 0 |
| K895818 | STEADFAST DENTURE ADHESIVE CREAM | Stiefel Research Institute, Inc. | 1990-04-03 | 186 | 0 |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. | 1988-11-01 | 15 | 0 |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Block Drug Company, Inc. | 1987-06-30 | 21 | 0 |
| K854430 | RIGIDENT CREAM | Armkel, LLC | 1986-03-04 | 119 | 0 |
| K831493 | DENTURE ADHESIVE SEALS | Johnson & Johnson Professionals, Inc. | 1983-06-30 | 51 | 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