K042848 is an FDA 510(k) clearance for the FRC POSTEC PLUS. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on November 22, 2004, 38 days after receiving the submission on October 15, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.
| 510(k) Number | K042848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2004 |
| Decision Date | November 22, 2004 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELR — Post, Root Canal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3810 |