K162311 is an FDA 510(k) clearance for the Straumann PrefGel. This device is classified as a Cleanser, Root Canal.
Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on March 7, 2017, 201 days after receiving the submission on August 18, 2016.
This device falls under the Dental FDA review panel.
| 510(k) Number | K162311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2016 |
| Decision Date | March 07, 2017 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ — Cleanser, Root Canal |
| Device Class | — |