The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Glidewell Appliance Resin, Hard/soft.
| Device ID | K214102 |
| 510k Number | K214102 |
| Device Name: | Glidewell Appliance Resin, Hard/Soft |
| Classification | Mouthguard, Prescription |
| Applicant | Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 |
| Contact | Jiahe Li |
| Correspondent | Jiahe Li Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-29 |
| Decision Date | 2022-02-23 |