FDA.report

510(k) K071410

Device
ARGEN PEARL BRAND ZIRCONIA
Applicant
THE ARGEN CORPORATION
510(k) number
K071410
Product code
EIH  
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-15
Date received
2007-05-21
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
PAUL CASCONE
Address
5855 Oberlin Dr. San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
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D818115035ArgenZ Ultra 95x22ARGEN CORPORATION, THE2022-03-14
D818115034ArgenZ Ultra 95x20ARGEN CORPORATION, THE2022-03-14
D818115033ArgenZ Ultra 95x18ARGEN CORPORATION, THE2022-03-14
D818115032ArgenZ Ultra 95x16ARGEN CORPORATION, THE2022-03-14
D818115031ArgenZ Ultra 95x14ARGEN CORPORATION, THE2022-03-14
D818115030ArgenZ Ultra 95x12ARGEN CORPORATION, THE2022-03-14
D818115029ArgenZ Ultra 95x10ARGEN CORPORATION, THE2022-03-14
D818114779ArgenZ Ultra 98x25SARGEN CORPORATION, THE2022-03-14
D818114777ArgenZ Ultra 98x22SARGEN CORPORATION, THE2022-03-14
D818114776ArgenZ Ultra 98x20SARGEN CORPORATION, THE2022-03-14
D818114775ArgenZ Ultra 98x18SARGEN CORPORATION, THE2022-03-14
D818114774ArgenZ Ultra 98x16SARGEN CORPORATION, THE2022-03-14
D818114773ArgenZ Ultra 98x14SARGEN CORPORATION, THE2022-03-14
D818114772ArgenZ Ultra 98x12SARGEN CORPORATION, THE2022-03-14
D818114771ArgenZ Ultra 98x10ARGEN 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

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FDA Review

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