K231305
- 510(k) number
- K231305
- Device name
- Endoform Dental Membrane
- Applicant
- Aroa Biosurgery , Ltd. NZ
- Product code
- NPL — Barrier, Animal Source, Intraoral
- Decision date
- 2024-01-23
- Date received
- 2023-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 4.2 MB · U.S. public domain
Also available from FDA: K231305.pdf
Official FDA record: K231305
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.