K113839 is an FDA 510(k) clearance for the RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE. This device is classified as a Cord, Retraction.
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on April 12, 2012, 106 days after receiving the submission on December 28, 2011.
This device falls under the Dental FDA review panel.
| 510(k) Number | K113839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2011 |
| Decision Date | April 12, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |