K852540 is an FDA 510(k) clearance for the ULTRASONIC TOOTH SCALER MODEL DSCIOP. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 1, 1985, 17 days after receiving the submission on June 14, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K852540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1985 |
| Decision Date | July 01, 1985 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |