K251605
- 510(k) number
- K251605
- Device name
- DIMPLO Implant System
- Applicant
- DIMPLO, Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-12-22
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251605.pdf
Official FDA record: K251605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.