The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for J. Morita Az Ultrasonic System.
| Device ID | K053030 |
| 510k Number | K053030 |
| Device Name: | J. MORITA AZ ULTRASONIC SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Howard Rowe |
| Correspondent | Howard Rowe J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2005-11-07 |