K062731 is an FDA 510(k) clearance for the ULTRASONIC SCALER, VARIOS 560. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on May 1, 2007, 230 days after receiving the submission on September 13, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K062731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2006 |
| Decision Date | May 01, 2007 |
| Days to Decision | 230 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 |