K131997 is an FDA 510(k) clearance for the NEWTRON BOOSTER. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Satelec - Acteon Group (Mt. Laurel, US). The FDA issued a Cleared decision on November 26, 2013, 151 days after receiving the submission on June 28, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K131997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2013 |
| Decision Date | November 26, 2013 |
| Days to Decision | 151 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 |