K234142
- 510(k) number
- K234142
- Device name
- TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
- Applicant
- Megagen Implant Co., Ltd. KR
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2024-09-18
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K234142.pdf
Official FDA record: K234142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.