K862876 is an FDA 510(k) clearance for the NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM. This device is classified as a Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt (Class I - General Controls, product code KOO).
Submitted by Block Drug Company, Inc. (Jersey City, US). The FDA issued a Cleared decision on August 29, 1986, 30 days after receiving the submission on July 30, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3490.
| 510(k) Number | K862876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1986 |
| Decision Date | August 29, 1986 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KOO — Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3490 |