K993545 is an FDA 510(k) clearance for the TENAX WHITE POST. 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 April 14, 2000, 178 days after receiving the submission on October 19, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.
| 510(k) Number | K993545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1999 |
| Decision Date | April 14, 2000 |
| Days to Decision | 178 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 |