Submission Details
| 510(k) Number | K973236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1997 |
| Decision Date | March 11, 1998 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |