K143655 is an FDA 510(k) clearance for the SICAT OPTIMOTION. This device is classified as a Mouthguard, Prescription.
Submitted by Sicat GmbH & Co. KG (Bonn, DE). The FDA issued a Cleared decision on October 2, 2015, 283 days after receiving the submission on December 23, 2014.
This device falls under the Dental FDA review panel.
| 510(k) Number | K143655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2014 |
| Decision Date | October 02, 2015 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |