FDA.report

510(k) K150919

Device
ArgenZ Esthetic Plus
Applicant
THE ARGEN CORPORATION
510(k) number
K150919
Product code
EIH  
Decision
Substantially Equivalent (SESE)
Decision date
2015-07-13
Date received
2015-04-06
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
CRAIG JOLICOEUR
Address
5855 Oberlin Dr. San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
D818130189ArgenZ ST 98x20 ML B4BARGEN CORPORATION, THE2022-03-14
D818118921ArgenZ Anterior 98x14SARGEN CORPORATION, THE2022-03-14
D818130175ArgenZ ST 98x12 ML OM3BARGEN CORPORATION, THE2022-03-14
D818130176ArgenZ ST 98x14 ML OM3BARGEN CORPORATION, THE2022-03-14
D818130177ArgenZ ST 98x16 ML OM3BARGEN CORPORATION, THE2022-03-14
D818130178ArgenZ ST 98x18 ML OM3BARGEN CORPORATION, THE2022-03-14
D818130179ArgenZ ST 98x20 ML A1BARGEN CORPORATION, THE2022-03-14
D818130180ArgenZ ST 98x20 ML A2BARGEN CORPORATION, THE2022-03-14
D818130181ArgenZ ST 98x20 ML A3BARGEN CORPORATION, THE2022-03-14
D818130182ArgenZ ST 98x20 ML A3.5BARGEN CORPORATION, THE2022-03-14
D818130183ArgenZ ST 98x20 ML B1BARGEN CORPORATION, THE2022-03-14
D818130184ArgenZ ST 98x20 ML B2BARGEN CORPORATION, THE2022-03-14
D818130185ArgenZ ST 98x20 ML C1BARGEN CORPORATION, THE2022-03-14
D818130186ArgenZ ST 98x20 ML C2BARGEN CORPORATION, THE2022-03-14
D818130187ArgenZ ST 98x20 ML D2BARGEN CORPORATION, THE2022-03-14
D818130188ArgenZ ST 98x20 ML OM2BARGEN CORPORATION, THE2022-03-14
D818130239ArgenZ ST 95x16 ML A3.5BARGEN CORPORATION, THE2022-03-14
D818130190ArgenZ ST 98x20 ML C3BARGEN CORPORATION, THE2022-03-14
D818130191ArgenZ ST 98x20 ML OM3BARGEN CORPORATION, THE2022-03-14
D818130192ArgenZ ST 98x20 ML D3BARGEN CORPORATION, THE2022-03-14
D818130193ArgenZ ST 98x20 ML OM1BARGEN CORPORATION, THE2022-03-14
D818130194ArgenZ ST 98x20 ML D4BARGEN CORPORATION, THE2022-03-14
D818130195ArgenZ ST 98x20 ML B3BARGEN CORPORATION, THE2022-03-14
D818130196ArgenZ ST 98x20 ML A4BARGEN CORPORATION, THE2022-03-14
D818130197ArgenZ ST 98x20 ML C4BARGEN CORPORATION, THE2022-03-14
D818130217ArgenZ ST 95x14 ML A1BARGEN CORPORATION, THE2022-03-14
D818130218ArgenZ ST 95x14 ML A2BARGEN CORPORATION, THE2022-03-14
D818130219ArgenZ ST 95x14 ML A3BARGEN CORPORATION, THE2022-03-14
D818130236ArgenZ ST 95x16 ML A1BARGEN CORPORATION, THE2022-03-14
D818130237ArgenZ ST 95x16 ML A2BARGEN CORPORATION, THE2022-03-14

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
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
K250811Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2025-04-11

Legacy Summary

summary

FDA Review

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