K231395
- 510(k) number
- K231395
- Device name
- INNO SLA Submerged Narrow Implant System
- Applicant
- Cowellmedi Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-10-18
- Date received
- 2023-05-15
- 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: K231395.pdf
Official FDA record: K231395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.