510(k) K233434
K233434 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)". The FDA issued a decision of Substantially Equivalent on November 14, 2023. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2023
- Date Received
- October 13, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type