K932255 is an FDA 510(k) clearance for the YOUNG D'GRANULATOR. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on April 15, 1994, 340 days after receiving the submission on May 10, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K932255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1993 |
| Decision Date | April 15, 1994 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KMW - Handpiece, Rotary Bone Cutting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |