K243731
- 510(k) number
- K243731
- Device name
- HEXIM Implant; Samwon General Abutments
- Applicant
- P&A USA VA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-07-09
- Date received
- 2024-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243731.pdf
Official FDA record: K243731
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.