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510(k) K182833

Device
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
Applicant
The Argen Corporation
510(k) number
K182833
Product code
EIH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-02-08
Date received
2018-10-09
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
No

Applicant Contact#

Contact
Craig Jolicoeur
Address
5855 Oberlin Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EIH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253191DCMhotbond zirconDental Creativ Management GmbH2026-05-21
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
K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd.2025-07-10
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

Legacy Summary#

summary