K241127
- 510(k) number
- K241127
- Device name
- INNO SLA Mini Plus® Implant System
- Applicant
- Cowellmedi Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-12-27
- Date received
- 2024-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241127.pdf
Official FDA record: K241127
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.