Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH D | Procter & Gamble Co. | 1994-11-30 | 36 | 2 |
| K943486 | ORAFIX SPECIAL DENTURE ADHESIVE | Smithkline Beecham Corp. | 1994-11-03 | 107 | 0 |
| K930335 | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | Fittydent-Altwirth & Schmitt GmbH | 1994-02-01 | 375 | 0 |
| K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | 1986-08-29 | 30 | 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