K042056 is an FDA 510(k) clearance for the 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 September 30, 2004, 62 days after receiving the submission on July 30, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K042056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2004 |
| Decision Date | September 30, 2004 |
| Days to Decision | 62 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 |