K914513 is an FDA 510(k) clearance for the PALAVIT G. This device is classified as a Wax, Dental, Intraoral (Class I - General Controls, product code EGD).
Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 1992, 162 days after receiving the submission on October 9, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6890.
| 510(k) Number | K914513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1991 |
| Decision Date | March 19, 1992 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EGD — Wax, Dental, Intraoral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6890 |