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510(k) K201323

Device
INNO SLA Submerged Implant System
Applicant
Cowellmedi Co., Ltd.
510(k) number
K201323
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-25
Date received
2020-05-18
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Minjin Park
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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K253341Custom Abutments ASMedentika GmbH2025-12-23
K253312OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23
K252320SIMDA AbutmentsSimda Co., Ltd.2025-12-18