K914257 is an FDA 510(k) clearance for the DENTURE PRODUCT X. This device is classified as a Cleanser, Denture, Over The Counter (Class I - General Controls, product code EFT).
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on January 13, 1993, 478 days after receiving the submission on September 23, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3520.
| 510(k) Number | K914257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1991 |
| Decision Date | January 13, 1993 |
| Days to Decision | 478 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFT - Cleanser, Denture, Over The Counter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3520 |