FDA.reportPublic FDA data

510(k) K241972

Device
BLUEDIAMOND IMPLANT
Applicant
Megagen Implant Co., Ltd.
510(k) number
K241972
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-27
Date received
2024-07-05
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hyo-Eun Lee
Address
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun Deagu KR 42921 42921

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZE#

510(k), Device, Applicant table
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