K223798 is an FDA 510(k) clearance for the Glidewell TuffSplint™ Appliance Resin. This device is classified as a Mouthguard, Prescription.
Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on February 17, 2023, 60 days after receiving the submission on December 19, 2022.
This device falls under the Dental FDA review panel.
| 510(k) Number | K223798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2022 |
| Decision Date | February 17, 2023 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC — Mouthguard, Prescription |
| Device Class | — |