FDA.reportPublic FDA data

510(k) K223194

Device
Glass Ceramic
Applicant
Shenzhen Xiangtong Co., Ltd.
510(k) number
K223194
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-10
Date received
2022-10-13
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
Xue Gong
Address
2nd F., 1st Bldg., W. Area, Honghualing Industrial Park, #88, N. Zhuguang Rd., Nanshan Dist. Shenzhen CN 518055 518055

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
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
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