K053030 is an FDA 510(k) clearance for the J. MORITA AZ ULTRASONIC SYSTEM. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on November 7, 2005, 11 days after receiving the submission on October 27, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K053030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2005 |
| Decision Date | November 07, 2005 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |