KOOFDA Class 1 · 21 CFR 872.3490
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Device family · Dental
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
4
Manufacturers
1
Flagged signals
15
Adverse-event reports
566
Code matrix
| FDA product code | KOO |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3490 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2012 | 8 | 266.0 | 1,858 |
| Other | 2011 | 33 | 246.8 | 7,838 |
| Other | 2011 | 112 | 213.5 | 23,432 |
| Other | 2010 | 89 | 169.5 | 14,726 |
| Other | 2010 | 18 | 134.6 | 2,257 |
| Other | 2013 | 4 | 133.0 | 401 |
| Other | 2012 | 17 | 127.1 | 2,004 |
| Other | 2012 | 64 | 121.8 | 7,546 |
| Other | 2011 | 3 | 99.8 | 203 |
| Other | 2011 | 10 | 96.4 | 852 |
| Other | 2014 | 3 | 28.9 | 55 |
| Other | 2010 | 3 | 28.9 | 55 |
| Other | 2013 | 13 | 24.7 | 273 |
| Other | 2009 | 3 | 22.4 | 42 |
| Other | 2006 | 4 | 7.6 | 17 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 1 family · 566 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| PROCTER & GAMBLE CO. | 1 | 1994 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES · Procter & Gamble Co.510(k) · 1994-11-30
ORAFIX SPECIAL DENTURE ADHESIVE · Smithkline Beecham Corp.510(k) · 1994-11-03
PROFAST - DENTURE ADHESIVE FOR LOWER JAWS · Fittydent-Altwirth & Schmitt GmbH510(k) · 1994-02-01
NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM · Block Drug Company, Inc.510(k) · 1986-08-29
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.