K930335 is an FDA 510(k) clearance for the PROFAST - DENTURE ADHESIVE FOR LOWER JAWS. 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 Fittydent-Altwirth & Schmitt GmbH (Chicago, US). The FDA issued a Cleared decision on February 1, 1994, 375 days after receiving the submission on January 22, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3490.
| 510(k) Number | K930335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1993 |
| Decision Date | February 01, 1994 |
| Days to Decision | 375 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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 |