K111348 is an FDA 510(k) clearance for the RE / STASIS (TM) GINGIVAL RETRACTION PASTE. This device is classified as a Cord, Retraction.
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 22, 2011, 70 days after receiving the submission on May 13, 2011.
This device falls under the Dental FDA review panel.
| 510(k) Number | K111348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2011 |
| Decision Date | July 22, 2011 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |