K231513
- 510(k) number
- K231513
- Device name
- Oral Matrix
- Applicant
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd. CN
- Product code
- NPL — Barrier, Animal Source, Intraoral
- Decision date
- 2024-02-16
- Date received
- 2023-05-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K231513.pdf
Official FDA record: K231513
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.