FDA product code KOT: Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
KOT is the FDA product code for carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium. It is a Class I device, regulated under 21 CFR 872.3490 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under KOT, from 7 different applicants. The average 510(k) review took 68 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium |
| 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 KOT clearance
Top KOT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Block Drug Company, Inc. | 2 | 1994-12-20 |
| Medical Polymers, Inc. | 1 | 1994-04-22 |
| Teledyne Getz | 1 | 1990-10-24 |
| Stiefel Research Institute, Inc. | 1 | 1990-04-03 |
| Precision Dynamics Corp. | 1 | 1988-11-01 |
2 more applicants have KOT clearances. See the full list in Caduvo.
Most recent KOT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945462 | Block Drug Company, Inc. | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | 1994-12-20 | 43 |
| K941365 | Medical Polymers, Inc. | MPI DENTURE ADHESIVE FILM SEALS | 1994-04-22 | 32 |
| K903568 | Teledyne Getz | SUPER STRENGTH DENTURE ADHESIVE CREAM | 1990-10-24 | 78 |
| K895818 | Stiefel Research Institute, Inc. | STEADFAST DENTURE ADHESIVE CREAM | 1990-04-03 | 186 |
| K884357 | Precision Dynamics Corp. | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | 1988-11-01 | 15 |
Recalls for KOT devices
openFDA lists no recalls for product code KOT.
Frequently asked questions
What is FDA product code KOT?
KOT is the FDA product code for carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium. It is a Class I device, regulated under 21 CFR 872.3490 and reviewed by the Dental panel.
What device class is KOT?
Class I, regulation 21 CFR 872.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOT?
Across 8 cleared submissions the average was 68 days from receipt to decision (median 47).
Which companies have the most KOT clearances?
Block Drug Company, Inc. (2); Medical Polymers, Inc. (1); Teledyne Getz (1); Stiefel Research Institute, Inc. (1); Precision Dynamics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KOT
- Run a recall and safety report across every KOT manufacturer
- Watch product code KOT 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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