Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
This device is a denture adhesive containing carboxymethylcellulose sodium at a concentration of 40 to 100 percent, intended to secure removable dentures to the gums. It is classified as FDA Class 1, the lowest risk category, subject to general controls such as labeling and good manufacturing practices. The product code is KOQ, regulated under 21 CFR 872.3410 within the Dental specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KOQ
- Device Class
- FDA class 1
- Regulation Number
- 872.3410
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901882 | URESIL ENDOSCOPIC LASER OVERTUBE | Jul 27, 1990 | Substantially Equivalent | Uresil Corp. |
| K900401 | NAS&P GRASPING FORCEPS & ASSOC. DEVICES | Feb 09, 1990 | Substantially Equivalent | North American Sterilization & Packaging Co. |
| K896821 | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE | Feb 09, 1990 | Substantially Equivalent | North American Sterilization & Packaging Co. |
| K831265 | DENTOLOCK DENTURE ADHESIVE CREAM | May 09, 1983 | Substantially Equivalent | Solar Dental Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.