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510(k) K220079

Device
Magicore Narrow System
Applicant
Innobiosurg Co., Ltd.
510(k) number
K220079
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-14
Date received
2022-01-10
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
Ga Yun Kim
Address
44-19, Techno 10-Ro, Yuseong-Gu Daejeon KR 34027 34027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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