K063812 is an FDA 510(k) clearance for the STRAUMANN PREFGEL. This device is classified as a Cleanser, Root Canal.
Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on January 12, 2007, 21 days after receiving the submission on December 22, 2006.
This device falls under the Dental FDA review panel.
| 510(k) Number | K063812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ — Cleanser, Root Canal |
| Device Class | — |