Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
This device is a denture adhesive composed of either carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium, used to secure removable dentures within the oral cavity. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is KOT, regulated under 21 CFR 872.3490 in the Dental specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KOT
- Device Class
- FDA class 1
- Regulation Number
- 872.3490
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Dec 20, 1994 | Substantially Equivalent | Block Drug Company, Inc. |
| K941365 | MPI DENTURE ADHESIVE FILM SEALS | Apr 22, 1994 | Substantially Equivalent | Medical Polymers, Inc. |
| K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Oct 24, 1990 | Substantially Equivalent | Teledyne Getz |
| K895818 | STEADFAST DENTURE ADHESIVE CREAM | Apr 03, 1990 | Substantially Equivalent | Stiefel Research Institute, Inc. |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Nov 01, 1988 | Substantially Equivalent | Precision Dynamics Corp. |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Jun 30, 1987 | Substantially Equivalent | Block Drug Company, Inc. |
| K854430 | RIGIDENT CREAM | Mar 04, 1986 | Substantially Equivalent | Armkel, LLC |
| K831493 | DENTURE ADHESIVE SEALS | Jun 30, 1983 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.