FDA product code KOO: Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
KOO is the FDA product code for adhesive, denture, polyvinyl methylether maleic acid calcium-sodium double salt. It is a Class I device, regulated under 21 CFR 872.3490 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under KOO, from 4 different applicants. The average 510(k) review took 137 days (median 72). FDA has posted 3 recalls for KOO devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt |
| Device class | Class I |
| Regulation | 21 CFR 872.3490 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KOO clearance
Top KOO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Procter & Gamble Co. | 1 | 1994-11-30 |
| Smithkline Beecham Corp. | 1 | 1994-11-03 |
| Fittydent-Altwirth & Schmitt GmbH | 1 | 1994-02-01 |
| Block Drug Company, Inc. | 1 | 1986-08-29 |
Most recent KOO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945200 | Procter & Gamble Co. | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | 1994-11-30 | 36 |
| K943486 | Smithkline Beecham Corp. | ORAFIX SPECIAL DENTURE ADHESIVE | 1994-11-03 | 107 |
| K930335 | Fittydent-Altwirth & Schmitt GmbH | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | 1994-02-01 | 375 |
| K862876 | Block Drug Company, Inc. | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | 1986-08-29 | 30 |
Recalls for KOO devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code KOO?
KOO is the FDA product code for adhesive, denture, polyvinyl methylether maleic acid calcium-sodium double salt. It is a Class I device, regulated under 21 CFR 872.3490 and reviewed by the Dental panel.
What device class is KOO?
Class I, regulation 21 CFR 872.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOO?
Across 4 cleared submissions the average was 137 days from receipt to decision (median 72).
Which companies have the most KOO clearances?
Procter & Gamble Co. (1); Smithkline Beecham Corp. (1); Fittydent-Altwirth & Schmitt GmbH (1); Block Drug Company, Inc. (1).
Have KOO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KOO
- Run a recall and safety report across every KOO manufacturer
- Watch product code KOO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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