FDA product code KOL: Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
KOL is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under KOL, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer |
| 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 KOL clearance
Top KOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Iodent, Co. | 1 | 1989-02-24 |
| Norcliff Thayer, Inc. | 1 | 1979-10-26 |
Most recent KOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884999 | Iodent, Co. | HOLD-FAST DENTURE ADHESIVE | 1989-02-24 | 85 |
| K791576 | Norcliff Thayer, Inc. | FORGET - DENTURE BONDING LIQUID | 1979-10-26 | 70 |
Recalls for KOL devices
openFDA lists no recalls for product code KOL.
Frequently asked questions
What is FDA product code KOL?
KOL is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel.
What device class is KOL?
Class I, regulation 21 CFR 872.3410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOL?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most KOL clearances?
Iodent, Co. (1); Norcliff Thayer, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KOL
- Run a recall and safety report across every KOL manufacturer
- Watch product code KOL 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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