K802515 is an FDA 510(k) clearance for the ROOT CANAL POST. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).
Submitted by Unitek Corp. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 28 days after receiving the submission on October 15, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.
| 510(k) Number | K802515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 28 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 |