K770367 is an FDA 510(k) clearance for the ROOT CANAL FILES & REAMERS. This device is classified as a Reamer, Pulp Canal, Endodontic (Class I - General Controls, product code EKP).
Submitted by Cemco Tool Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977, 7 days after receiving the submission on February 22, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K770367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1977 |
| Decision Date | March 01, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKP — Reamer, Pulp Canal, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |