K770997 is an FDA 510(k) clearance for the PRO-CARE. This device is classified as a Toothbrush, Powered (Class I - General Controls, product code JEQ).
Submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 20, 1977, 19 days after receiving the submission on June 1, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6865.
| 510(k) Number | K770997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1977 |
| Decision Date | June 20, 1977 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | JEQ - Toothbrush, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6865 |