K921604 is an FDA 510(k) clearance for the TOUCH N' HEAT, MODIFICATION. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by Analytic Technology (Redmond, US). The FDA issued a Cleared decision on August 24, 1992, 150 days after receiving the submission on March 27, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K921604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1992 |
| Decision Date | August 24, 1992 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |