K230618
- 510(k) number
- K230618
- Device name
- MegaGen Dental Implant Systems Portfolio - MR Conditional
- Applicant
- Megagen Implant Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-10-11
- Date received
- 2023-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K230618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.