K222778
- 510(k) number
- K222778
- Device name
- Osstem Implant System
- Applicant
- Osstem Implant Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-09-23
- Date received
- 2022-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K222778.pdf
Official FDA record: K222778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.