K251628
- 510(k) number
- K251628
- Device name
- Mandibular Advancement Device L07
- Applicant
- Dcstar, Inc. NY · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-10-22
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K251628.pdf
Official FDA record: K251628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.