FDA.reportPublic FDA data

510(k) K250673

Device
CERABIEN MiLai
Applicant
Kuraray Noritake Dental, Inc.
510(k) number
K250673
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-29
Date received
2025-03-06
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
N

Applicant Contact#

Contact
Yasujiro Ohara
Address
Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-Ku Tokyo JP 100-0004 100-0004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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
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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