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510(k) K202046

Device
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Applicant
Kj Meditech Co., Ltd.
510(k) number
K202046
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-01
Date received
2020-07-23
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
Hyukki Moon
Address
959-21 Daechon-Dong, Buk-Gu Gwang-Ju KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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