K854643 is an FDA 510(k) clearance for the SOLAR. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 14, 1986, 115 days after receiving the submission on November 19, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K854643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1985 |
| Decision Date | March 14, 1986 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |