510(k) K214102
K214102 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Glidewell Appliance Resin, Hard/Soft". The FDA issued a decision of Substantially Equivalent on Feb 23, 2022. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Prismatik Dentalcraft, Inc. has 58 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 23, 2022
- Date Received
- Dec 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)