K000311 is an FDA 510(k) clearance for the PARAPOST FIBER WHITE. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).
Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on March 14, 2000, 42 days after receiving the submission on February 1, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.
| 510(k) Number | K000311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2000 |
| Decision Date | March 14, 2000 |
| Days to Decision | 42 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 |