K860817 is an FDA 510(k) clearance for the ROOT CANAL ORGANIZER. This device is classified as a Carver, Wax, Dental (Class I - General Controls, product code EIK).
Submitted by Pacific Union Dental, Inc. (Silver Spring, US). The FDA issued a Cleared decision on March 17, 1986, 13 days after receiving the submission on March 4, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K860817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1986 |
| Decision Date | March 17, 1986 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIK — Carver, Wax, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |