FDA.reportPublic FDA data

510(k) K222707

Device
IH Implant System
Applicant
Sewonmedix, Inc.
510(k) number
K222707
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-07
Date received
2022-09-07
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
Jinsoo Lee
Address
#29, Sa-Sang-Ro, 375beon-Gil, Sa-Sang-Gu Sa-Sang-Gu KR 46700 46700

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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