FDA product code KOQ: Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
KOQ is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (40-100&). It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under KOQ, from 3 different applicants. The average 510(k) review took 48 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
| Device class | Class I |
| Regulation | 21 CFR 872.3410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KOQ clearance
Top KOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North American Sterilization & Packaging Co. | 2 | 1990-02-09 |
| Uresil Corp. | 1 | 1990-07-27 |
| Solar Dental Co., Inc. | 1 | 1983-05-09 |
Most recent KOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901882 | Uresil Corp. | URESIL ENDOSCOPIC LASER OVERTUBE | 1990-07-27 | 92 |
| K900401 | North American Sterilization & Packaging Co. | NAS&P GRASPING FORCEPS & ASSOC. DEVICES | 1990-02-09 | 11 |
| K896821 | North American Sterilization & Packaging Co. | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE | 1990-02-09 | 67 |
| K831265 | Solar Dental Co., Inc. | DENTOLOCK DENTURE ADHESIVE CREAM | 1983-05-09 | 21 |
Recalls for KOQ devices
openFDA lists no recalls for product code KOQ.
Frequently asked questions
What is FDA product code KOQ?
KOQ is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (40-100&). It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel.
What device class is KOQ?
Class I, regulation 21 CFR 872.3410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOQ?
Across 4 cleared submissions the average was 48 days from receipt to decision (median 44).
Which companies have the most KOQ clearances?
North American Sterilization & Packaging Co. (2); Uresil Corp. (1); Solar Dental Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KOQ
- Run a recall and safety report across every KOQ manufacturer
- Watch product code KOQ 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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