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510(k) K250811

Device
Dental Zirconia Ceramic
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) number
K250811
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-11
Date received
2025-03-17
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jeffry Ye
Address
#9 Dushan Rd. Economic And Technological Development Zone Qinhuangdao CN 066004 066004

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
K262074Any-ZircosMediclus Co., Ltd.2026-08-21
K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.2026-07-30
K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.2026-07-17
K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy2026-06-30
K260918Zolid LunarisAmann Girrbach AG2026-06-29
K260859Rosetta SM, Rosetta SPHass Corp.2026-06-11
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