FDA product code KXX: Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
KXX is the FDA product code for adhesive, denture, karaya and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3450 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under KXX. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer |
| Device class | Class I |
| Regulation | 21 CFR 872.3450 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KXX clearance
Top KXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Combe, Inc. | 1 | 1986-09-19 |
Most recent KXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863375 | Combe, Inc. | SEA-BOND | 1986-09-19 | 16 |
Recalls for KXX devices
openFDA lists no recalls for product code KXX.
Frequently asked questions
What is FDA product code KXX?
KXX is the FDA product code for adhesive, denture, karaya and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3450 and reviewed by the Dental panel.
What device class is KXX?
Class I, regulation 21 CFR 872.3450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXX?
Across 1 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most KXX clearances?
Combe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXX
- Run a recall and safety report across every KXX manufacturer
- Watch product code KXX 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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