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510(k) K222792

Device
SNUCONE Tissue Level Implant System
Applicant
Snucone Co., Ltd.
510(k) number
K222792
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-08
Date received
2022-09-16
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
Song Ha Eun
Address
5, Seongseo-Ro 75-Gil Dalseo-Gu KR 42703 42703

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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