K162164 is an FDA 510(k) clearance for the GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord. This device is classified as a Cord, Retraction.
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on January 13, 2017, 163 days after receiving the submission on August 3, 2016.
This device falls under the Dental FDA review panel.
| 510(k) Number | K162164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2016 |
| Decision Date | January 13, 2017 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |