K251491
- 510(k) number
- K251491
- Device name
- K5 Cart, K5 Mount, K5 Swing
- Applicant
- Osstem Implant Company., Ltd. Chair Business KR
- Product code
- EIA — Unit, Operative Dental
- Decision date
- 2025-07-17
- Date received
- 2025-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251491.pdf
Official FDA record: K251491
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.