K191836 is an FDA 510(k) clearance for the Ceramill A-Splint. This device is classified as a Mouthguard, Prescription.
Submitted by Amann Girrbach AG (Koblach, AT). The FDA issued a Cleared decision on December 20, 2019, 164 days after receiving the submission on July 9, 2019.
This device falls under the Dental FDA review panel.
| 510(k) Number | K191836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |