K240810
- 510(k) number
- K240810
- Device name
- Anti Grinding Guard
- Applicant
- Xiamen Yizhou Imp. & Exp. Co., Ltd. CN
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2024-05-24
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240810.pdf
Official FDA record: K240810
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.