K923549 is an FDA 510(k) clearance for the PALADISC LC. This device is classified as a Material, Impression Tray, Resin (Class I — General Controls, product code EBH).
Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on September 29, 1992, 75 days after receiving the submission on July 16, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3670.
| 510(k) Number | K923549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1992 |
| Decision Date | September 29, 1992 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBH — Material, Impression Tray, Resin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.3670 |