Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
This device is a denture adhesive formulated with polyvinyl methylether maleic acid calcium-sodium double salt, used to help retain removable dentures in place within the oral cavity. It is classified as FDA Class 1, meaning it presents low risk and is subject only to general controls such as proper labeling and manufacturing standards. The product code is KOO, and it is regulated under 21 CFR 872.3490 within the Dental specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KOO
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | Nov 30, 1994 | Substantially Equivalent | Procter & Gamble Co. |
| K943486 | ORAFIX SPECIAL DENTURE ADHESIVE | Nov 03, 1994 | Substantially Equivalent | Smithkline Beecham Corp. |
| K930335 | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | Feb 01, 1994 | Substantially Equivalent | Fittydent-Altwirth & Schmitt GmbH |
| K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Aug 29, 1986 | Substantially Equivalent | Block Drug Company, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.