K233434
- 510(k) number
- K233434
- Device name
- Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2023-11-14
- Date received
- 2023-10-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233434.pdf
Official FDA record: K233434
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.