FDA.reportPublic FDA data

510(k) K222686

Device
Perfit FS Dental Zirconia Fully Sintered Block
Applicant
Vatech Acucera, Inc.
510(k) number
K222686
Product code
EIH  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-06
Date received
2022-09-06
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
No

Applicant Contact#

Contact
Kwon Kyung Wook
Address
2544, Nambuk-Daero, Idong-Eup, Cheoin-Gu Yongin-Si KR 17138 17138

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
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
K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd.2025-07-10
K250826Multi M SeriesDmax Co., Ltd.2025-06-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases