K840141 is an FDA 510(k) clearance for the DENTAL ULTRASONIC SCALER/ENDOSONIC. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on March 16, 1984, 71 days after receiving the submission on January 5, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K840141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1984 |
| Decision Date | March 16, 1984 |
| Days to Decision | 71 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 |