K251434
- 510(k) number
- K251434
- Device name
- Healing Abutment System
- Applicant
- Osstem Implant Co., Ltd. KR
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2026-03-04
- Date received
- 2025-05-08
- 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: K251434.pdf
Official FDA record: K251434
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.