K031421 is an FDA 510(k) clearance for the ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT). This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Nakanishi, Inc. (Schaumburg, US). The FDA issued a Cleared decision on March 26, 2004, 326 days after receiving the submission on May 5, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K031421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2003 |
| Decision Date | March 26, 2004 |
| Days to Decision | 326 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 |