FDA.report

510(k) K260819

Device
Any-Com Seal
Applicant
Mediclus Co., Ltd.
510(k) number
K260819
Product code
EBC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2026-03-13
Regulation
872.3765
Classification name
Sealant, Pit And Fissure, And Conditioner
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ku Da Hyeon
Address
# 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si KR 28576 28576

FDA Registration Numbers

Source Documents

510(k) summary PDF

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