K242753
- 510(k) number
- K242753
- Device name
- SD TL Implant System
- Applicant
- Arum Dentistry Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-01-06
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242753.pdf
Official FDA record: K242753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.