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510(k) K241127

Device
INNO SLA Mini Plus® Implant System
Applicant
Cowellmedi Co., Ltd.
510(k) number
K241127
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-27
Date received
2024-04-23
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
Donghyung Lee
Address
48, Hakgam-Daero 221beon-Gil, Sasang-Gu Busan KR 46986 46986

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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