Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
The Karaya and Ethylene-Oxide Homopolymer Denture Adhesive is a dental device composed of karaya gum and a synthetic polymer used to enhance the fit and retention of removable dentures, improving comfort and function for denture wearers. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KXX, regulated under 21 CFR 872.3450, in the Dental medical specialty. No special flags apply to this device.
Research product code KXX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KXX
- Device Class
- FDA class 1
- Regulation Number
- 872.3450
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863375 | SEA-BOND | Sep 19, 1986 | Substantially Equivalent | Combe, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.