The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Visioner 21-a.
| Device ID | K901037 |
| 510k Number | K901037 |
| Device Name: | VISIONER 21-A |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Ronald D Newman |
| Correspondent | Ronald D Newman J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-08-14 |