K203000 is an FDA 510(k) clearance for the KeyPrint KeySplint Hard. This device is classified as a Mouthguard, Prescription.
Submitted by Mycone Dental Supply Co. Inc. (Dba Keystone Industries) (Gibbstown, US). The FDA issued a Cleared decision on April 9, 2021, 190 days after receiving the submission on October 1, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K203000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2020 |
| Decision Date | April 09, 2021 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |