K162536 is an FDA 510(k) clearance for the GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord. This device is classified as a Cord, Retraction.
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on February 3, 2017, 144 days after receiving the submission on September 12, 2016.
This device falls under the Dental FDA review panel.
| 510(k) Number | K162536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2016 |
| Decision Date | February 03, 2017 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |