K214102 is an FDA 510(k) clearance for the Glidewell Appliance Resin, Hard/Soft. This device is classified as a Mouthguard, Prescription.
Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on February 23, 2022, 56 days after receiving the submission on December 29, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K214102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2021 |
| Decision Date | February 23, 2022 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC — Mouthguard, Prescription |
| Device Class | — |