K896693 is an FDA 510(k) clearance for the FLEXI-CAST CROWN CORE SYSTEM. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).
Submitted by Essential Dental Systems, Inc. (New York, US). The FDA issued a Cleared decision on February 14, 1990, 78 days after receiving the submission on November 28, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.
| 510(k) Number | K896693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1989 |
| Decision Date | February 14, 1990 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | ELR - Post, Root Canal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3810 |