FDA.report

510(k) K250063

Device
ARENA Star, Galaxy Star
Applicant
Arum Dentistry Co., Ltd.
510(k) number
K250063
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-10
Date received
2025-01-10
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Choi Won-Yi
Address
23 Gukjegwahak 11-Ro, Yuseong-Gu Daejeon KR 34002 34002

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08809924583512ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08800055727424Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583116ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583123ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583130ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583147ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583154ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583161ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583178ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583185ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583192ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583208ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583215ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583222ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583239ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583246ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759997Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583529ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583536ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583574ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583581ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583598ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583635ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583642ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809924583659ARENA StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759935Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759942Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759959Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759966Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12
08809982759973Galaxy StarARUM DENTISTRY Co., Ltd.2026-03-12

Other 510(k) Records For Product Code EIH

510(k)DeviceApplicantDecision date
K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation2026-04-09
K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd.2026-03-30
K253953IPS e.max ZirconiaIvoclar Vivadent, Inc.2026-03-10
K254283BruxZir® Shaded 16 PLUSPrismatik Dentalcraft, Inc.2026-01-30
K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesLiaoning Upcera Co., Ltd.2026-01-09
K252789Glass CeramicShenzhen Xiangtong Co., Ltd.2025-12-08
K252446BruxZir® NOWPrismatik Dentalcraft, Inc.2025-09-03
K251593DenMat Multilayered Zirconia DiscDenmat Holding, LLC2025-08-25
K250826Multi M SeriesDmax Co., Ltd.2025-06-12
K251084zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG2025-06-05
K250673CERABIEN MiLaiKuraray Noritake Dental, Inc.2025-05-29
K250534Biomic Color OpaqueAidite (Qinhuangdao) Technology Co., Ltd.2025-05-20
K250393ZircaGlow & ZircaGlow HT ZirconiaUnited Zirconia2025-05-12
K250811Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2025-04-11
K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )Aidite (Qinhuangdao) Technology Co., Ltd.2025-03-14