K162948 is an FDA 510(k) clearance for the Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials. This device is classified as a Cord, Retraction.
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on August 8, 2017, 291 days after receiving the submission on October 21, 2016.
This device falls under the Dental FDA review panel.
| 510(k) Number | K162948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2016 |
| Decision Date | August 08, 2017 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |