K113530 is an FDA 510(k) clearance for the ULTRASONIC SCALER. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on January 31, 2013, 428 days after receiving the submission on November 30, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K113530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2011 |
| Decision Date | January 31, 2013 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |