510(k) K223798
K223798 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Glidewell TuffSplint Appliance Resin". The FDA issued a decision of Substantially Equivalent on February 17, 2023. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2023
- Date Received
- December 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type