K242287
- 510(k) number
- K242287
- Device name
- SFIT Abutment
- Applicant
- Cowellmedi Co., Ltd. KR
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-09-16
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K242287.pdf
Official FDA record: K242287
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.