FDA.reportPublic FDA data

510(k) K212765

Device
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant
Bloomden Bioceramics (HuNan) Co., Ltd.
510(k) number
K212765
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-15
Date received
2021-08-31
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
Shengyong Liao
Address
#301, 5th Bldg., Hi-Tech Int'L Enterprise Port Liandong U Valley, Linyu Rd. Changsha CN 410000 410000

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
K262685Zirconia Collective 4Y Dental Zirconia BlankZirconia Collective, Inc.2026-10-30
K262756Zirconia Dental Ceramics and Staining SolutionFanen New Materials Technology (Suzhou) Co., Ltd.2026-10-29
K262980INNI-CERA (BCM-W500, BCM-W1000)DentMedi Co., Ltd.2026-10-21
K262523Amber ArteHass Corp.2026-10-16
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