K850666 is an FDA 510(k) clearance for the STROBEX ULTRON ELECTROSURGE-DENTAL UNIT. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by Ipco Corp. (White Plains, US). The FDA issued a Cleared decision on May 29, 1985, 98 days after receiving the submission on February 20, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K850666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1985 |
| Decision Date | May 29, 1985 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |