Submission Details
| 510(k) Number | K864500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1986 |
| Decision Date | March 19, 1987 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |