K923586 is an FDA 510(k) clearance for the BURNOUT MATERIAL. This device is classified as a Wax, Dental, Intraoral (Class I - General Controls, product code EGD).
Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 29, 1992, 71 days after receiving the submission on July 20, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6890.
| 510(k) Number | K923586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1992 |
| Decision Date | September 29, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGD — Wax, Dental, Intraoral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6890 |