K903284 is an FDA 510(k) clearance for the YOUNG PROPHY SYSTEM, PS UNIT. This device is classified as a Airbrush (Class II - Special Controls, product code KOJ).
Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on December 17, 1990, 148 days after receiving the submission on July 22, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.
| 510(k) Number | K903284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1990 |
| Decision Date | December 17, 1990 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | KOJ - Airbrush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6080 |