K922380 is an FDA 510(k) clearance for the BITE RIM WAX. 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 June 16, 1992, 27 days after receiving the submission on May 20, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6890.
| 510(k) Number | K922380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1992 |
| Decision Date | June 16, 1992 |
| Days to Decision | 27 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 |