KOO — Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Class I
FDA product code KOO covers "Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt", a Class I medical device regulated under 21 CFR 872.3490. Submissions are reviewed by the Dental panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOO
- Device Class
- Class I
- Regulation Number
- 872.3490
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K945200 | procter and gamble | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | November 30, 1994 |
| K943486 | smithkline beecham | ORAFIX SPECIAL DENTURE ADHESIVE | November 3, 1994 |
| K930335 | fittydent-altwirth and schmitt | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | February 1, 1994 |
| K862876 | block drug company | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | August 29, 1986 |