K123215 is an FDA 510(k) clearance for the VISCOSTAT CLEAR. This device is classified as a Cord, Retraction.
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 5, 2013, 113 days after receiving the submission on October 15, 2012.
This device falls under the Dental FDA review panel.
| 510(k) Number | K123215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2012 |
| Decision Date | February 05, 2013 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |