K822620 is an FDA 510(k) clearance for the ROOT CANAL REAMERS, TYPE K. This device is classified as a Reamer, Pulp Canal, Endodontic (Class I - General Controls, product code EKP).
Submitted by Union Broach, Div. Moyco Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1982, 29 days after receiving the submission on August 30, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K822620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1982 |
| Decision Date | September 28, 1982 |
| Days to Decision | 29 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 |