K901037 is an FDA 510(k) clearance for the VISIONER 21-A. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on August 14, 1990, 161 days after receiving the submission on March 6, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K901037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1990 |
| Decision Date | August 14, 1990 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKS — File, Pulp Canal, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |