FDA.report

510(k) K253461

Device
Demi Pro
Applicant
Meta Systems Co., Ltd.
510(k) number
K253461
Product code
EBZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-14
Date received
2025-10-07
Regulation
872.6070
Classification name
Activator, Ultraviolet, For Polymerization
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Related Records

Applicant Contact

Contact
Ray Jeon
Address
#1214-18, Sicox Tower 12f, 484, Dunchon-Daero, Jungwon-Gu Seongnam-Si KR 13229 13229

FDA Registration Numbers

Source Documents

510(k) summary PDF

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